Blog Tag: Medical Device

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system (the “IlluminOss System”).  According to the FDA, the de novo clearance is reserved for new, novel devices whose type has not been previously classified.

IlluminOss, a privately held commercial-stage medical device company based in East Providence, Rhode Island, describes itself as being involved in the development and commercialization of minimally invasive fracture fixation techniques.  The company explains that the newly-approved IlluminOss Bone Stabilization System is used for the treatment of impending and actual pathological fractures of the humerus, radius, and ulna resulting from metastatic bone disease.

Traditional bone stabilization procedures utilizing invasive techniques and intramedullary rods can risk causing extensive soft tissue damage and reduced patient mobility.  Moreover, the metal plates and rods may increase patients’ risk of cortical porosis, delayed bridging, and refractures upon removal.  Regarding its IlluminOss System, IlluminOss states:

The IlluminOss System was developed with an aim to provide improved patient experiences and outcomes when treating pathologic fractures. There is a critical need to make less invasive orthopedic fracture repair options available to an aging and underserved market segment.

In contrast to traditional fixation techniques, the IlluminOss explains that its System uses a small-diameter PET balloon and visible light fiber, each of which may be threaded through a 4.5 mm pathway into the medullary canal through a small incision in the patient’s skin.  Once inserted, the PET balloon is filled with a photoactive liquid monomer, causing the balloon to expand and conform to the specific shape of the patient’s bone.  With the liquid-filled balloon in place, the photoactive monomer is polymerized utilizing the visible light fiber, resulting in a hardened implant which conforms to the patient’s specific bone structure within 90 seconds.  The hardened implant stabilizes the fracture by providing both longitudinal and rotational stability across the length of the implant.

The IlluminOss System has been available internationally since 2010.  IlluminOss reports success in international markets: surgeons have reported smaller incisions, shorter procedure times, and a faster return to the patient’s daily living activities.  Reduced complication rates, and shorter hospital stays have also been observed.

With marketing clearance in hand, IlluminOss plans to initiate U.S. commercialization efforts in the second quarter of 2018.

Popular Social Media Platforms in the Pharma Industry

Social Media Success: Trends in Pharma Digital Strategies

According to data published by business intelligence firm Cutting Edge Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital marketing strategies over the next one to two years.

According to Cutting Edge Information, “[i]n these strategy meetings, teams consider several factors, including the target patient population, therapeutic area and geographic region.” For example, “region can affect strategies because each country has its own pharma marketing rules and regulations.”

The survey, which included marketing teams from companies such as GlaxoSmithKline, Johnson & Johnson, Chiesi, Janssen, Mallinckrodt, and Takeda, also revealed that YouTube (64%) was the second most popular among the pharmaceutical marketing teams, while LinkedIn (55%) and Twitter (45%) rounded out the top four.

Not as popular, but still commonly used social networking sites include Instagram (18%) and Vimeo, Google+, Tumblr, and SlideShare each with 9% of pharmaceutical marketing teams utilizing them. Interestingly, additional data from the study show that no surveyed pharmaceutical or medical device companies reported using Pinterest, Vine, Flickr or Reddit.

Digital Currencies and Blockchain in the Medical Arena

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain technology allows for a distributed and cryptographically secure ledger without the use of traditional banking institutions. Newer and more advanced digital currencies have recently been introduced with the added advantage of smart contracts, which are said to be self-executing contractual clauses that may be programmed into a digital currency transaction. As such, many new digital currencies have been appearing with individuals investing in Initial Coin Offerings (ICOs), which are somewhat akin to the Initial Public Offerings (IPOs) of a traditional corporation.

Even more recently, a few companies have begun to make use of digital currencies and blockchain technology in the medical arena. Many have found blockchain technology uniquely suited to secure patient records, and have found that the smart contracts of digital currencies may allow individuals greater control of their medical data. Below is a summary of a few fields of medicine and companies within those fields in which digital currencies and blockchain are already being developed.

Medical Records and Health Data

According to The Merkle, Bowhead Health is the first medical device company using their AHT digital currency tokens with smart contracts to create a new medical data market. The company plans to allow individuals with Bowhead’s digital currency to control the dissemination of their medical data, and also to compensate those individuals if and when they choose to share with research institutions. Bowhead’s AHT tokens are said to allow 70% of research fees to be distributed to users with the other 30% going to token holders.

According to Blockchain News, Medicalchain is a UK-based company using blockchain technology to allow patients to securely store and send their medical records to their healthcare professionals. Medicalchain is said to allow patients to have a centralized medical record accessible from anywhere in the world, and allow individuals the ability to control medical institutions’ access to their records.

The Medical Society of Delaware has partnered with the company Medscient, and they are using blockchain technology to create a proof-of-concept platform to allow insurers and medical care providers to access patient records, according to The Cointelegraph. The article further states that this partnership was made possible when the state of Delaware became the first state to pass a law allowing the use of blockchain technology in business for stock trading and record-keeping.

Medical Licenses

The Illinois Blockchain Initiative has partnered with Hashed Health to create a pilot program to streamline the process of issuing and tracking medical licenses, according to The Cointelegraph. The goal of this partnership is said to give patients and healthcare providers a transparent license registry system that uses smart contracts to automatically update information.

Medicine and Artificial Intelligence (AI)

According to news sources, Doc.ai is a collaboration between developers from the universities of Stanford and Cambridge, and is said to be creating a platform built on blockchain technology and using AI to create a resource to answer patient’s specific questions regarding their personal health records and their physician’s analysis.

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon based in Nashville, Tennessee.  A recent published application relating to the subject matter can be found here.  FIG. 3 of that application, said to illustrate a 3D model printing method, and FIG. 7 said to illustrate an intervertebral cage apparatus are reproduced below.

 

EIT describes itself as a German medical device manufacturer specializing in implants for spinal alignment.  In July 2017, a news article noted that EIT received approval from the U.S. Food and Drug Administration (FDA) to commercialize its spinal interbody product offerings.  Regarding EIT’s acquisition, Guntmar Eisen, co-founder and CEO of EIT, stated:

“This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages.  This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”

According to PRWeb, the first functional spinal fusion cages based on this patent acquisition will be launched in 2018.

Pediatric Healthcare Innovators Compete for Funding

Pediatric Healthcare Innovators Compete for Funding

The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care.  The FDA defines “pediatric” as encompassing devices used for patients who are 21 years of age or younger at the time of diagnosis or treatment.

Many of the consortia hold innovation competitions where winners are awarded grants and support services. For example, PR Newswire reports that the New England Pediatric Device Consortium (NEPDC) has awarded three companies grants and in-kind services for products aimed at preventing the dislodgement or unintended removal of catheters or tubing.  According to NEPDC’s Request for Abstracts, the grants are up to $50,000 each.  NEPDC offers quarterly grant opportunities; the next abstract deadline for grant funding is October 9, 2017, with applications due on October 23, according to PR Newswire.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) has narrowed a record number of 98 applications from across the globe down to twelve finalists, according to PR Newswire. This is the 5th annual Pediatric Device Innovation Symposium hosted by NCC-PDI, a FDA-funded consortium led by the Sheikh Zayed Institute for Pediatric Surgical Innovation and A. James Clark School of Engineering at the University of Maryland according to the competition’s homepage.  NCC-PDI highlights that up to six finalists will be awarded up to $50,000 each after the presentations held on September 24, 2017.

Another consortia, the Atlantic Pediatric Device Consortium (APDC), announced that it will hold Round 1 winner presentations at its 7th annual Pediatric Device Innovation Competition on September 25, 2017.  The proposal deadline was July 31, 2017, and award winners will be notified on October 30, 2017, according to APDC.

Also, in January of 2017, the Philadelphia Pediatric Medical Device Consortium (PPDC) announced that it chose three companies from eight finalists to receive seed grants of $50,000 each.  The PPDC announced that the Request for Applications for its next Sponsored Project Proposals begins on September 11, 2017.

According to a 2016 FDA review, the FDA-funded pediatric consortia have advised 406 pediatric device projects and innovators since 2013, and as of the first fiscal quarter of 2016 there were 10 patents obtained and 5 devices available for use in the care for pediatric patients.

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Wayne, Pennsylvania-based Teleflex Inc.  announced it will purchase privately-held NeoTract Inc. for approximately $1.1 billion. According to the press release, Teleflex will pay NeoTract $725 million when the deal closes and an additional $375 million upon NeoTract hitting certain sales goals through 2020. The companies said they expect the deal to close within the next 30 days.

According to its website, Teleflex is a global provider of medical technologies in surgical, anesthesia, cardiac care, urology, and respiratory care fields.  NeoTract describes itself as a company dedicated to developing minimally-invasive and clinically-effective devices that address unmet needs in the field of urology. NeoTract’s device, the UroLift® System, is said to treat benign prostrate hyperplasia (BPH) by using small implants to hold the enlarged prostate tissue out of the way of the urethra.

Teleflex’s CEO Benson Smith characterized NeoTract as “a truly unique company with a differentiated technology that targets a greater than $30 billion addressable market.” Smith also stated that a second-generation UroLift® System is expected to launch in the second half of 2018. NeoTract’s revenue is expected to be between $115 million to $120 million this year, compared to about $51 million in 2016, and is expected to increase at least 40 percent in 2018, the companies said in a joint statement.

Reuters notes that the deal is Teleflex’s 23rd since 2008 and follows its $1 billion acquisition of Vascular Solutions in December. Teleflex expects the NeoTract deal to slightly diluteTeleflex’s adjusted earnings this year, be neutral to profits next year, and be accretive starting in 2019.

Nanochip Device with Potential To Heal Tissue and Organs

According to a regenerative medicine article published online on August 07, 2017 in the journal Nature Nanotechnology titled “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue”, Researchers at the Ohio State University Wexner Medical Center and College of Engineering have developed a technology that has the potential to generate any cell type of interest for treatment within a patient’s body. According to the article, the researchers call their technology Tissue Nanotransfection (“TNT”), and state that a chip-sized device may be used to repair injured tissue or restore the function of aging tissue.  This can include, for example, organs, blood vessels and nerve cells.

Dr. Chandan Sen, the director of Ohio State’s Center for Regenerative Medicine & Cell Based Therapies and the executive director of Ohio State’s Comprehensive Wound Center states that “by using our novel nanochip technology, injured or compromised organs can be replaced. We have shown that skin is a fertile land where we can grow the elements of any organ that is declining.”

Sen further states that “This is difficult to imagine, but it is achievable, successfully working about 98 percent of the time. With this technology, we can convert skin cells into elements of any organ with just one touch. This process only takes less than a second and is non-invasive, and then you’re off. The chip does not stay with you, and the reprogramming of the cell starts. Our technology keeps the cells in the body under immune surveillance, so immune suppression is not necessary.”

According to the Nature Nanotechnology article, the TNT chip-sized device has two major components – (1) a nanotechnology-based chip that sits on the skin, and (2) biological cargo contained within to affect the tissue underneath.

As illustrated in the figure above, the chip is said to deliver pre-programmed DNA or RNA non-invasively into living skin cells using a high-intensity, focused electric field and converting it into whatever type of cells chosen.  “This technology does not require a laboratory or hospital and can actually be executed in the field,” Sen said. “It’s less than 100 grams to carry and will have a long shelf life.”  “We are proposing the use of skin as an agricultural land where you can essentially grow any cell of interest,” Sen said.

According to the article, initial testing on mice has been promising.  The researchers reported that they were able to reprogram skin cells into vascular cells on a mouse that had a badly injured leg with no blood flow. The article noted that as shown in the figure below, after one week of treatment, blood vessels appeared around the leg and within two weeks the leg had been completely restored.

Furthermore, the article noted that a mouse that suffered a stroke regained neurologic function, demonstrating that this technology could also be applied to organs and nerve cells.

According to researchers, the aforementioned technique is said to be unique as it skips the usual intermediary step of creating pluripotent stem cells.  Furthermore, the article notes that because the process is non-invasive and the reprogrammed cells are part of the patient’s body, there are no concerns regarding immune suppression.

The Medical Device Tax Lives On

For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns.  However, following the failure of repeal legislation that would have killed off, or delayed, the tax, the tax is on pace to be reinstated on January 1st, 2018 after a two-year gap.

Regardless of the status of the Affordable Care Act, news articles have indicated that companies and lawmakers opposed to the tax are considering pursuing a number of different options, such as adding tax delay language into other bills.  Accordingly, a group of conservative action groups are pushing Congressional leaders to pursue a repeal of the tax, including preparing a letter to House speaker Paul Ryan and Senate majority leader Mitch McConnell.  Further, the Advanced Medical Technology Association will be running digital and social media ads throughout this month in a number of states, hoping for tax repeal once lawmakers are back in session in September.

While it can be difficult to truly define a correlation between job performance and the medical device tax, a member survey performed by the Medical Device Manufacturers Association found that 70% of companies added jobs in 2016-2017 and R&D increased by 19% on average.  On the other hand, in 2015 the Congressional Research Service found that there were no significant losses due to the tax.

According to news sources, the tax applies to hospital and physician medical equipment, but excludes many consumer medical items (eyeglasses, hearing aids, etc.).

 

K2M Obtains Exclusive License to Patent Portfolio

K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology.  According to K2M, the company is a global leader in the medical device industry and provides complex spine and minimally invasive solutions to help patients with difficult spinal pathologies achieve three-dimensional (i.e., axial, coronal, and sagittal) Total Body Balance™.  K2M explains that the acquisition of the “comprehensive patent portfolio” allows the company to expand its portfolio of 3D-printed spinal solutions.

In the same press release, K2M also announced its plan to integrate its 3D printing technology, Lamellar 3D Titanium Technology™,  into new products developed with the recently acquired intellectual property.  According to K2M’s Platform Technologies page, Lamellar 3D Titanium Technology™ utilizes an advanced 3D printing method to grow implants from titanium powder through selective application of a high-energy laser beam.

Speaking about the exclusive license, Eric Major, K2M President and CEO, stated:

We are excited to have obtained the exclusive rights to this intellectual property portfolio and look forward to integrating our 3D printing technology with new expandable spinal devices as part of our effort to build a comprehensive portfolio of industry-leading, 3D-printed solutions to address the full range of spinal pathologies.

K2M recently expanded its portfolio of 3D-printed spinal solutions in June 2017 after receiving FDA clearance of MOJAVE™ PL 3D Expandable Interbody System, which is a fusion device designed to allow for independent adjustment of the anterior and posterior height in the lumbar spine.  K2M also introduced its SAHARA™ AL Expandable Stabilization System in June, which is the only expandable, lordotic interbody device currently available that uses an integrated screw fixation to help achieve spinal balance.

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.

Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM three years ago according to press releases.  The Excelsius GPSTM platform is said to function as a robot-assisted surgery guidance system “designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement,” according to the press release.  Globus Medical further describes the platform as being compatible for use with pre-operative CT, intra-operative CT, and fluoroscopic imaging modalities.

The FDA’s decision is stated to allow the platform for use within minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications in spine and orthopedic surgery.  This announcement also follows Globus Medical’s earlier news release announcing that the Excelsius GBSTM system received CE mark approval in the European Union.

Norbert Johnson, Vice President of Robotics, Imaging, & Navigation at Globus Medical, views these results as an example of Globus Medical’s developmental capabilities:

We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.

The Excelsius GPSTM received FDA 510(k) clearance after Globus Medical re-filed its 510(k) bid following an FDA decision that Globus Medical’s initial bid had not “sufficiently addressed the FDA’s questions,” according to Mass Device.

House Passes Bill Relaxing Reporting Requirements

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017.  This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA.  Previously, companies had to submit a report within 30 days of  a problem.  Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.

This measure is part of a piece of legislation that must be renewed every five years and which sets the fees that device makers pay the FDA to review their products. The goal of the agreement from the device maker’s perspective is to reduce the time it takes for the FDA to review products and get them to market. According to the New York Times, this bill “compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever.” But this may not be in patients’ best interest, because medical device malfunctions are already “vastly underreported” as acknowledged by the FDA.

StarTribune reports that proponents of the change say that it would “simplify the needlessly repetitive process of reporting known product problems.” Minneapolis-based med-tech regulatory attorney Mark DuVal said that “A lot of MDRs (Medical Device Reports) are really boilerplate and repetitive,” and that “[i]t would be nice to be able bundle them.” According to the StarTribune, DuVal thinks that the current system of reporting MDR’s creates a lot of work for companies while doing little to inform doctors about issues that are known. Janet Trunzo, a senior executive vice president with the lobbying group AdvaMed, said in a statement that the reporting provision “will allow the agency to better focus its resources on more serious reportable events.” According to Trunzo, the quarterly summary reporting only applies to well-understood and familiar malfunction incidents. Medical device companies would still be required to file an individual report on any malfunction incident that had not been previously reported.

According to the New York Times, critics of the change do not think relaxing the rules is proper when so much already goes unreported. Jack Mitchell, director of health policy for the National Center for Health Research, said that “[p]ost-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” Mitchell thinks that loosening up the reporting rules will “exacerbate the tendency to underreport.” Ms. Tomes, who is now the chief executive of Device Events, which mines FDA’s device data to find signals of problems, also does not think this loosening of the reporting rules is in the public’s best interest. Ms. Tomes pointed out that last year, many reports about battery depletion of cardiac defibrillators were reported as “malfunctions.”

The bill still needs to be passed in the Senate before being signed into law by President Trump.

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k).  The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”

According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements.  Further, the Notice indicates there are limitations on some of the exemptions.  Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR).  Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table.  Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.

The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.”  Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”

The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016.  According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter.  The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year.  The relevant codified language for each listed device will be amended by the FDA in a “future action.”

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the Prescription Drug User Fee Act, the Medical Device User Fee Amendments, the Generic Drug User Fee Amendments, and the Biosimilar User Fee Act.

 

The Trump Administration’s Statement includes the following recommendation:

 

“The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs.  In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”

 

This call for the FDA to be fully funded by user fees paid by medical-device and pharmaceutical companies echoes previous statements from the Trump White House.  In May, the Trump Administration released its budget proposal for Fiscal Year 2018, which called for the elimination of federal funding of premarketing review programs at FDA.  Trump’s budget proposed that FDA user fees should be recalibrated from approximately $1.2 billion in 2017 to over $2.4 billion in 2018.  The FDA currently receives about 60% of its funding for premarketing review from user fees.

 

Scott Gottlieb, the newly confirmed FDA commissioner, has expressed his support for increasing user fees as a way for funding FDA activities.  FDA’s budget request for 2018 seeks $3.2 billion in user fees—a reported increase of 68 percent from 2017 levels.

 

Some industry experts have expressed concern that a large increase in FDA user fees could discourage innovation and keep smaller companies such as digital startups from entering the market. Increasing FDA user fees would also complicate existing user fee agreements that FDA negotiated with the medical device industry last summer.

 

While the future of user fees remains uncertain, the Trump Administration and FDA’s persistence in calling for higher user fees suggests that fee hikes could be looming—a development that could have major effects on the medical device industry.

Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s recent interactions with the  FDA.

First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices.  MassDevice reports that is recalling well over 7,000 of the affected devices.

Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device.  The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions.  As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.

In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx.  According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm.  This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.

In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection.  Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific.  Ms. Shrader called for standardization of inspections by the FDA.

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™.  The myBETAapp joins the growing field of medical mobile applications, which the FDA predicts will reach 1.7 billion smartphone or tablet users by 2018.

According to Bayer, the myBETAapp connects their BETACONNECT autoinjector (for delivering BETASERON®, a therapeutic agent for multiple sclerosis) to a patient’s mobile device or computer, and the BETACONNECT Navigator functions as a tool to view data uploaded by the myBETAapp.

According to the myBETAapp user instructions, the application will:

  • Display scheduled injections according to an injection routine
  • Allow the user to determine when an injection is scheduled
  • Display suggested injection sites based on the injection sites shown in the prescribing information for BETASERON®
  • Display a monthly calendar of recorded, missed, and scheduled injections
  • Transfer and sync data recorded by the autoinjector to the corresponding injection in the calendar
  • Send a notice to record injection data to the patient via email

In the press release, Bayer describes the myBETAapp and BETACONNECT Navigator as allowing further connection between the patient and the healthcare team by, with the patient’s permission, providing access to the patient’s injection history. The application is also advertised as providing further connectivity to a BETA Nurse for patients enrolled in BETAPLUS®, Bayer’s patient support program.

According to Dr. Kantor, President Emeritus, Florida Society of Neurology:

The myBETAapp and BETACONNECT Navigator work cohesively together to support communication and connection between people living with relapsing remitting multiple sclerosis and their BETA Nurse and health care team.

Bayer reports that the myBETAapp will be available for free download from the Apple app store, Google Play Store, or Betaseron.com by mid-July 2017.

 

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017.  The report recommends various protective actions for hospitals to take and points to critical differences in the protection of medical device systems as opposed to general hospital systems.

According to the report, ransomware makes data, software, and IT assets unavailable to users.  The report describes ransomware as using the encryption of data to hold systems hostage, where the hacker promises to give the victims access to their data if a ransom is paid.  One previous ransomware example reported on the Knobbe Medical Device Blog was the WannaCry virus, a ransomware that caused disruptions for several hospitals in the United Kingdom.  The International Business Times reported that security researchers had found that the WannaCry ransomware was not limited to computers but also capable of exploiting medical devices.

The ECRI Institute report explains that an IT department can use new security patches for some medical device systems; however, some systems will remain susceptible because they are based on an older version of an operating system and can’t be upgraded or they have not been validated for clinical use with the latest security patches. 

The report includes a list of dos and don’ts for quickly responding to emerging threats.  The “Dos” mentioned in the report include:

  • Identify medical devices, servers or workstations that may be affected.
  • Contact the device vendor. 
  • Request written copies of the manufacturer’s recommended actions for dealing with a current ransomware threat. 

The “Don’ts” mentioned in the report include:

  • Don’t overreact.
  • Don’t install unvalidated patches.  Unvalidated patches can make medical devices faulty or inoperable.  Ask the manufacturer for documentation of the validation.

The ECRI Institute is a nonprofit organization that has its U.S. headquarters in Plymouth Meeting, Pennsylvania.

Philips Buys RespirTech for Undisclosed Amount

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which help fight respiratory disease. According to a news release, the terms of the deal were not disclosed.

RespirTech’s website states that the inCourage vest uses high-frequency chest compression to help loosen and move mucus through the lungs. According to RespirTech’s website, the inCourage technology was developed by Pediatric Pulmonologist Warren Warwick, M.D., and Leland Hansen, MPH, in the early 1990’s to provide more effective secretion clearance for University of Minnesota cystic fibrosis patients.

According to Philips’ website, the conglomerate has primary divisions in the areas of healthcare, lighting, and home electronics. Philips’ 2016 annual report states that sales in its HealthTech portfolio increased 4% and topped $19 billion. In contrast, news sources state that RespirTech was founded in 2004 and reportedly had nearly $37 million in revenue in 2015.

Regarding the acquisition, John Frank, Philips’ business leader for sleep and respiratory care, said in a news release:

With this transaction, we will broaden our portfolio with a proven therapy to enable patients with chronic respiratory disorders manage their condition and receive the care they need in the home.

According to Philips’ CEO, Franz van Houten, Philips has transformed itself over the last five years into a differentiated global health tech leader. Mr. van Houten stated that the markets Philips’ serve have attractive growth and attractive profitability. According to news sources, GE Healthcare, Siemens Healthineers, and Toshiba Medical Systems are other conglomerate divisions competing with Philips in the healthcare space.

As one analyst notes, the Twin Cities have produced a number of competing companies that make vests for treating lung conditions, including New Prauge-based ElectroMed Inc., and St. Paul-based Hill-Rom.

FDA Approves “First-of-its-kind” Infant Medical Device

FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.

According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:

“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”

Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.

According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017.

According to the press release, Abbott produces the Confirm RxTM ICM, which is marketed as the slimmest ICM available. Pictured on the right, Abbott states that the Confirm RxTM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlinTM mobile app, thereby allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.  As noted on the Confirm RxTM webpage, the ICM is placed by a physician under local anesthesia by making a small incision in the pectoral region, inserting the ICM under the skin using an insertion tool, and then closing the incision. “Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator,” said Georg Nölker, M.D. in prepared remarks.  Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark approval.

According to Abbott, the myMerlinTM mobile app makes it easy for patients to stay connected to their physicians.  A listing of the product features from the Confirm RxTM product website includes:

  • Transmit nightly data reports automatically simply by being in range of the smartphone;
  • Manually record patient symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate;
  • Confirm patient data was transmitted to their physician;
  • Automatic alerts when they have missed a scheduled transmission;
  • Offers secure transmission of patient data.

Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses, views these results as a step forward in ICM technology, stating:

Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance…The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.

Dr. Christopher Piorkowski, said to be one of the first physicians to implant the Confirm RxTM ICM, stated:

The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.

As reported by the press release, the Confirm RxTM ICM is available in select European countries, with full European release expected during the second quarter of 2017.  It further states that the device is currently under review by the U.S. Food and Drug Administration.

WannaCry Malware and Medical Device Security

The WannaCry virus has infected and frozen computers in many industries around the world.  According to a news source report, the virus has extorted doctors and hospital administrators for the keys to unlock and regain access to their systems in order to treat patients.  The Telegraph reports that in the United Kingdom alone, up to 40 hospital trusts were hit by the WannaCry ransomware virus, which resulted in a wave of cancelled appointments and a general state of disarray.  Recently, the BBC has stated that at least 16 of these hospitals are still facing issues.  With the widespread damage associated with the WannaCry virus, many experts have advocated that the medical device industry should be on alert, now more than ever, regarding the cyber security of their medical devices.

Although the issues associated with medical device security have recently been discussed, some industry professionals believe there does not seem to be an adequate solution to the problem of device security.  Tressa Springman, the CIO of LifeBridge Health, explains:

“There’s a lot of talk in healthcare about device security. Discussions about what we’re comfortable pushing as endpoint security and what we’re unable to do – because certainly, we don’t want to create any harm to patients.  Many of these devices and the vendors who manage them, it’s very hard to go direct on patching and adding security.”

While medical devices are generally tested extensively for safety, some cybersecurity experts have observed the same cannot necessarily be said for security.  Brian NeSmith, co-founder and CEO of cyber security company Arctic Wolf Networks, has stated:

“Medical devices, similar to many other IoT devices, were not designed with rigorous security in mind and are more vulnerable to being hacked. They also do not fall under normal security operations procedures since they are used as needed by the medical practitioners and not deployed and maintained by the IT department.”

Security experts are emphasizing the importance of security patches.  Optimistically, Richard Staynings, the principal cybersecurity healthcare leader at Cisco’s Security unit, believes:

“This is going to cause a paradigm shift, at least for patching.”