Blog Tag: Medtronic
On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.” The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.”
The ‘141 patent discloses using stress and temperatures below body temperature to restrain a metal alloy. The alloy expands to its original shape after being released from its restraint and exposed to body temperature. In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure. Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.
The petition seeks to review all claims of the ‘141 Patent. Cook Medical’s petition submits two grounds on which the claims of the ‘141 Patent should be found invalid due to obviousness. The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.
This is not the first time that the ‘141 patent has been subject to a petition for inter partes review. On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of the patent for review of all claims of the ‘141 Patent. According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”
In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent. Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft. According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.
The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue. The parties entered into a confidential settlement in 2009.
Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007. AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue. The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million. AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and is expected to be launched in the United States before the end of July 2018.
DBS therapy involves the delivery of electrical stimulation to specific areas of the brain using a surgically-implanted device. About 125,000 Medtronic Activa devices are implanted globally. Medtronic’s Activa DBS system is used as therapy for neurological diseases including Dystonia and Parkinson’s disease.
The Activa Programming Application is designed for use with the Samsung Galaxy Tab S2 tablet. According to Medtronic’s press release, the purpose of the application is to “enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients.” The programmer is expected to have an immediate impact on thousands of patients’ post-implant care. For example, the programmer will allow the service life of certain Activa rechargeable implantable neurostimulators to be extended by 6 years, giving patients about 15 years between device replacement surgeries.
Dr. Mohammad Maarouf, associate professor, head of the Department of Stereotaxy and Functional Neurosurgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Germany stated that the programmer’s “intuitive, visual interface and task-based workflow makes daily use easier, saving [him] time to focus on what’s most important-[his] patients.”
According to Medtronic’s press release, Medtronic’s DBS Clinician Programmer is also approved for use with the Activa DBS systems for treating refractory epilepsy, which will be launched in the United States later this year.
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to Medtronic, the Intellis platform features the world’s smallest implantable spinal cord stimulator (SCS), which includes an implantable pulse generator that looks like an older-style pacemaker, but with wire leads that delivers mild current to a spinal vertebra. The Intellis, and other SCS systems deliver, neurostimulation at the spinal cords to prevent pain signals from reaching the brain.
The MIT Technology Review reports that SCS systems carry promise because they represent an alternative to opioid-based pain management. It is estimated that more than 20,000 Americans a year die from overdoses of prescription pain drugs. Government and industry alike recognize the gravity of the opioid issue. FDA Commissioner Dr. Scott Gottlieb has stated that opioid abuse is is taking a staggering human and economic toll and is therefore a top priority. Industries are also responding with ever-improving SCS systems (Medtronic’s pain-therapies business show $825 million in revenue during the company’s 2017 fiscal year).
According to Medtronic, the Intellis system allows physicians to better address the subjective and personal nature of patient’s chronic pain. Based on recorded and tracked patient activity, including body positions and how patients self-administer their therapy, Intellis allows a physician to program and manage pain therapy for each patient with a wirelessly connected Samsung tablet.
We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform . . . Samsung’s Galaxy tablets — secured by the HIPAA-ready Samsung Knox mobile security platform — will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions.
Medtronic is not the only industry player to explore cross-industry partnership: at least one of its competitors, Abbott (which acquired St. Jude and its line of chronic pain treatment devices in January, 2017) offers SCS devices featuring controllers made by Apple.
According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.
Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within the ENT anatomy during surgery and allows surgeons to track the locations of instruments during procedures, much like a GPS system used for cars. The surgeons can view 3-D structures on a 27-inch, high-resolution touch-screen monitor. Medtronic already markets a similar system, the StealthStation™ S8, for use in neurosurgery and spine procedures.
The press release reports that StealthStation™ ENT system provides surgeons with enhanced visualization during procedures and also includes several software and hardware innovations such as Virtual Endoscopy. Virtual Endoscopy gives surgeons a simulated view of a patient’s sinus cavities that have previously been unavailable using traditional endoscopy. Thus, Medtronic explains, a surgeon can load a Virtual Endoscopy with a patient’s pre-operative data and practice that patient’s surgery prior to setting foot in the operating room.
The StealthStation™ ENT system should enhance patient outcomes and provide a valuable tool to surgeons. Dr. Joseph Raviv, director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem commented:
The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery . . . . It provides an added level of assurance and may allow for a more thorough sinus procedure.
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.
Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.
The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.
Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:
As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.
Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.
With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3% medical device excise tax. While currently being suspended through 2017, under the present law the medical device tax would be reinstated in 2018.
Some producers of medical devices hope that the tax is never reinstated. Mark Throdahl, president and CEO of OrthoPediatrics Corp., a northern Indiana based orthopedic company, has said that the suspension of the tax allowed the company to hire new workers and hopes for a full repeal after the Republican transition. According to Throdahl, the tax led to a hiring freeze, and suspension of the tax allowed for them to resume “an aggressive pace of hiring and investment.” Complaints from companies like OrthoPediatrics, as well as medical device associations like AvaMed, were what led to the initial temporary suspension of the tax.
The medical device tax has been a significant drag on medical innovation, and resulted in the loss or deferred creation of jobs, reduced research, spending and slowed capital expansion.
According to some lawmakers, lobbyists, and industry executives, Trump and U.S. lawmakers will likely repeal the tax which could help some of the larger medical device manufacturers such as Medtronic, Boston Scientific, St. Jude Medical, and Johnson & Johnson. Senate Republican Leader Mitch McConnell has stated that repealing the Affordable Care Act will be one of the first order of business starting in January. Senator John Barrasso (R-Wyoming) has also stated that the medical device tax would likely be repealed.
There are still a number of decisions on how to approach the repeal of the medical device tax, whether in one single bill to repeal the Affordable Care Act or a number of smaller bills removing different parts of the Act. We should be receiving more clarity once President-elect Donald Trump officially takes office.
Repeal of the tax may remove approximately $2.5 billion of annual federal funding.
OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016, in Irvine, California. The speakers for this year’s MDIF include Mike Mussallem, Chairman and CEO of Edwards Lifesciences; Tom Burns, President and CEO of Glaukos; Jim Mazzo, Global President of Ophthalmology, Carl Zeiss Meditec; Brett Wall, Sr. VP and President of Brain Therapies, Medtronic; and Geoff Martha, EVP and Group President of Restorative Therapies Group, Medtronic. A number of companies will also present new strategies for maximizing funding options. The forum is expected to attract over 600 attendees.
According to its website, OCTANe fosters a successful ecosystem that accelerates the flow of ideas, talent, and capital by creating an infrastructure where entrepreneurs, academia, company executives, and business advisors build and grow sustainable organizations. OCTANe’s members include Orange County technology executive leaders, entrepreneurs, investors, venture capitalists, academicians, and strategic advisors, all working together to fuel innovation in the OC. OCTANe has helped more than 800 companies via the LaunchPad™ Small Business Development Center (SBDC) accelerator. LaunchPad™-certified companies are reported to have received more than $1.7 billion in investment and equity exits.
The agenda for this year’s MDIF includes a keynote address by Dr. Wallace Walrod, Chief Economic Adviser of the Orange County Business Council, and Herm Cukier, Sr. VP of Eye Care, Allergan, on Allergan’s economic impact on Orange County. A panel moderated by Clay Wilemon, CEO and Chief Strategy Officer of DevicePharm, will discuss using big data to improve patient outcomes and reimbursement. Sabing Lee, a Partner at Knobbe Martens, will host a panel discussing medical device security. And, U.S. Congresswoman Mimi Walters will address the importance of innovation in Orange County, and healthcare legislative and policy expert Jeff Kimbell will provide his views on the upcoming elections from a Washington D.C. perspective.
OCTANe annually welcomes more than 7,000 people to its programs and events, and more than 2,000 business leaders throughout the Orange County region are OCTANe members. Bill Carpou, CEO of OCTANe, describes the MDIF as “the most important event of the year when it comes to medical technology and Orange County.”
Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples of each type of pacemaker, both produced by Medtronic, are shown to the left). Medtronic states that the device provides select patients suffering from bradycardia with a minimally invasive treatment approach.
The Micra TPS, which is comparable in size to a large vitamin (as seen to the right), attaches to the heart with small tines and delivers electrical impulses that pace the heart. Thanks to its size and wireless technology, the Micra TPS does not require
leads under the patient’s skin. As such, the Micra TPS eliminates potential sources of complications that may be associated with more traditional pacemakers. Artist’s renderings comparing the Micra TPS and a traditional pacemaker when implanted are shown below.
Following what Medtronic describes as “the largest and longest clinical evaluation of leadless pacing patients to date,” the company released several statistics from its Micra TPS Global Clinical Trial that highlight the device’s long-term successes, including:
- 96% freedom-from-complication rate
- When compared to traditional pacemaker systems, the risk of
- major complications was reduced by 48% across all patient subgroups including age, gender and comorbidity
- hospitalization was lowered by 47%, and
- revision procedures was 82% lower
- The battery is projected to last an average of 12 years, based on data from 644 patients who have had the device for at least 12 months.
Regarding these results, John Liddicoat, M.D., senior vice president at Medtronic, stated:
The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers . . . . The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.
These statistics follow preliminary results published in the New England Journal of Medicine in November 2015, showing that the Micra TPS was successfully implanted in 99.2% of patients. Medtronic interprets the studies as demonstrating consistent and sustained results from early performance through 12-month follow-up.
Dr. John Hummel, a cardiologist who participated in the clinical trials, explains his view that Medtronic’s wireless pacing technology is the future of pacemaker therapy.
We are looking at the beginning of the future . . . . We will no longer pace the heart in the way we have in the last 20 to 30 years. This is fundamentally a paradigm shift in how we’ll deliver this therapy.
The Micra TPS was awarded its CE Mark in April 2015. Additionally, the device was approved by the FDA for use in the United States in April 2016. The device is presently the only leadless pacemaker approved for use in both the United States and Europe.
The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven cervical implant and its first to be approved for use in both one-level and two-level procedures. The system was approved to treat single-level cervical disc disease in July of 2014, and approval for use at two adjacent levels was granted earlier this month. As described in Medtronic’s press release, the ball-and-trough design of the Prestige LP allows a variety of movements including bending, rotation, and translation.
According to Medtronic, the Prestige LP Cervical System serves as a complete replacement for one or two intervertebral discs. The human spinal column is composed of twenty four vertebral bones stacked on top of each other. The uppermost seven bones are referred to as the cervical vertebrae, and they are labeled C1 – C7. Flexible intervertebral discs (Fig. 2 below) act as shock absorbers between adjacent vertebrae. Each disc is composed of an inner jelly-like material called the nucleus pulposus and a tough outer wrapping called the annulous fibrosus. In addition to cushioning shock, the discs allow bending, twisting, and flexion of the spine.
According to the Arthritis Foundation, wear and tear on intervertebral discs is part of normal aging. As we grow older, the discs can dry out and lose their shock absorbing capacity. Stress from daily activities can cause tears in the annulous fibrosus resulting in herniation of the inner jelly-like core. Furthermore, because intervertebral discs have little blood supply, their ability for self-repair is limited. As a result, once a disc is injured, it may continue to deteriorate. Studies using Magnetic Resonance Imaging (MRI) show that nearly everyone over age 60 has at least some disc degeneration. However, not all people affected by disc degeneration will experience discomfort. According to the American Academy of Orthopaedic Surgeons, pain and disability due to cervical disc degeneration are often treated with physical therapy, anti-inflammatory medications, and steroid injections. When these options fail to alleviate symptoms, surgical options may be considered.
According to the UCLA Spine Center, the traditional surgical approach to treating cervical disc disease involves removing the affected disc (called discectomy) and using metal hardware to fuse the vertebrae above and below it. The preferred procedure is called Anterior Discectomy and Cervical Fusion (ADCF). During ADCF, the diseased disc is removed and replaced with bone graft or a plastic spacer. Adjacent vertebrae are then fused using a metal plate and screws. Because normal cervical discs are flexible and permit movement of adjacent vertebrae, cervical discectomy and fusion can restrict neck motion. However, compared to this traditional approach, replacing a diseased disc with an implant can allow for greater neck motion after surgery and reduce stress on remaining vertebral bodies (Fig. 3 below).
The Medtronic Prestige LP Cervical Disc joins others that are FDA approved for use at two vertebral levels. In August, 2013 the Mobi-C Cervical Disc (Fig.
Medtronic PLC has announced it has agreed to acquire HeartWare International Inc. for $1.1 billion in cash. According to the press release, the acquisition will expand Medtronic’s portfolio of diagnostic tools and treatments for heart failure. The companies have said that they expect the deal to close during Medtronic’s second fiscal quarter, ending in late October.
HeartWare, a firm based in suburban Boston, creates minimally-invasive circulatory support technologies for the treatment of advanced heart failure. The HVAD® System, HeartWare’s flagship product, is the first and most widely studied centrifugal ventricular assist device (VAD), designed to facilitate the heart’s blood-pumping function. According to the HeartWare website, the HVAD System is the world’s smallest VAD, weighing only 160 grams, allowing for a less invasive implantation procedure and resulting in improved patient recovery times and outcomes.
Doug Godshall, HeartWare’s president and chief executive, said in a statement that the deal gives HeartWare “a unique opportunity to enhance growth in the mechanical circulatory support market.” Mike Coyle, executive vice president and president of the Cardiac and Vascular Group at Medtronic, stated:
“The team at HeartWare has established excellent relationships with its hospital customers and built a strong position and reputation in the marketplace.”
Medtronic estimates that the global VAD market is about $800 million now and is expected to grow by a percentage in the mid-to-high single digits in the current year and accelerate to a percentage in the high-single, low-double digits in the future.
Medtronic said that it did not expect to adjust its fiscal year 2017 revenue outlook or earnings as a result of the acquisition, and that it expected the deal to contribute to earnings in year three.
HeartWare is one of the two major VAD makers to be acquired within the last 12 months. Thoratec was acquired by St. Jude Medical for about $3.3 billion in October 2015. Abbott in turn agreed to acquire St. Jude for $25 billion in April of this year.
Smith & Nephew recently announced that it will sell its gynecology business to Medtronic for $350 million. As part of the sale, Medtronic will obtain Smith & Nephew’s key gynecological surgical solution, called the TRUCLEAR System. The System is a medical technology platform used to remove abnormal uterine tissue such as polyps and fibroids for diagnostic biopsy. According to Smith & Nephew’s press release, the TRUCLEAR System generated about $56 million in revenue in 2015, which represented approximately 1% of Smith & Nephew’s total revenues.
Regarding the decision to sell its gynecology business, Olivier Bohuon, CEO of Smith & Nephew, stated:
Smith & Nephew’s management team has a strong track record of creating value through organic growth and by acquisition. The sale of our Gynaecology business demonstrates our disciplined strategic approach to capital deployment and to crystallising value through divestiture at the right time.
The quality of the Gynaecology business was reflected by the strong interest from potential buyers, allowing us to obtain an attractive valuation. Our shareholders will benefit directly from the return of the proceeds through a share buy-back programme, in-line with our capital allocation framework. Gynaecology and its employees will benefit from a new owner with a synergistic platform looking to take the business to the next level.
Smith & Nephew completed five acquisitions in 2015, primarily focusing on robotic surgery and sports medicine. For example, in October of 2015, Smith & Nephew announced that it would acquire Blue Belt Holdings, Inc. for $275 million to secure its position in the orthopedic robotics-assisted surgery.
A burst of potential acquisitions and consolidations occurred on April 28th in the medical device world, the largest being Abbott Laboratories‘ deal to acquire St. Jude Medical Inc. The deal is for $25 billion dollars and would bring together two of the leaders in cardiac-related medical devices. It allows Abbott to boost its medical-device sector to compete with competitors Medtronic PLC and Boston Scientific Corp.
In particular, according to press releases, St. Jude has a strong portfolio in heart failure devices, atrial fibrillation, and cardiac rhythm management which will complement Abbott’s portfolio of cardiac intervention devices and transcatheter mitral repair. Certain medical devices produced by both companies can be used to alleviate the burden of cardiovascular disease, where more than 40% of adults are expected to experience some sort of cardiovascular disease by 2030.
“The combined business will have a powerful pipeline ready to deliver next-generation medical technologies and offer improved efficiencies for health care systems around the world.”
However, investors do not appears nearly as confident as Abbott’s stock fell by nearly 6 percent after the acquisition.
Abbott further has a pending deal to acquire the diagnostics company Alere Inc. for $5.8 billion. Other deals included Sanofi SA’s offer to purchase Medivation Inc. and AbbVie Inc.‘s offer to purchase Stemcentrx Inc. These consolidations appear to be attempts to improve negotiating power of the companies with hospitals.
However, this news may not be surprising to some. According to MedCityNews, the OsteoCool RF Ablation System was originally developed by Baylis Medical as a device for treating cancers that metastasize to the spine. Baylis Medical received 510(k) clearance for the original OsteoCool device in March 2012, a second version of the device in June 2015, and a third version of the device in November, 2015.
Medtronic purchased the OsteoCool RF Ablation System from Baylis Medical on December 16, 2015 for an undisclosed amount. According to Medtronic, the two companies have decided to partner up in order to further innovate the OsteoCool System.
Radiofrequency ablation systems use probes that deliver targeted radiofrequency energy to destroy cancer cells. According to Medtronic, the OsteoCool System uses a pair of internally water-cooled radiofrequency probes to ablate cancerous legions in the spine that have metastatized from other cancers. The water cooling controls the temperature of the probes and prevents overheating of surrounding tissue during the procedure. The pair of bipolar probes in the OsteoCool System may also be used simultaneously and are available in various lengths, allowing for the OsteoCool System to be configured to accommodate a variety of patient and procedural needs.
According to StreetInsider, this means that the OsteoCool System is currently the only cooled radiofrequency (RF) ablation technology that offers simultaneous, customizable dual-probe capability to allow for procedural flexibility and repeatability.
According to its website, Minneapolis-based Medtronic, Inc. is a global leader in medical technology that employs over 40,000 people. The company develops, manufactures, and markets medical devices that include implantable pacemakers and cardioverter defibrillators (ICDs), heart stents and valves, spinal discs, insulin pumps, continuous glucose monitoring systems, deep brain stimulation, neurostimulation for chronic pain, and remote monitoring and diagnostic products for chronic disease management.
According to its website, Baylis Medical Company is a supplier of high-technology cardiology, endovascular, and oncology products. Some of the products developed by Baylis include RF Puncture Systems and Devices such as the NRG RF Transseptal Needle for transseptal punctures in cardiac and vascular tissue.
The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc. Reuters reports that the all-stock transaction is valued at about $3.3 billion. Plans for the merger were first announced in October 2014, and approved by the shareholders of both companies in June 2015, subject to receipt of clearance by the FTC. Progress on the transaction was suspended when the FTC expressed concerns that the merger would reduce competition for total ankle replacements and total silicone rubber (silastic) toe replacements in the U.S. market.
The FTC’s Bureau of Competition enforces U.S. antitrust laws and works with the Bureau of Economics to investigate alleged anticompetitive business practices. On occasion, the Bureau urges the Commission to take law enforcement action. In this case, the FTC’s concerns were the final obstacle to the proposed merger. The recent final order, which follows a mandatory public comment period, settles the FTC’s allegations of anticompetitive behavior.
The order calls for Tornier to sell a portion of its U.S. assets and IP rights to Integra Lifesciences Corporation (NASDAQ: IART), a competitor in the U.S. orthopedics space, which is based in Plainsboro, New Jersey. The newly combined company will be required to provide Integra with ankle and toe replacement products for up to three years. Through this arrangement, the FTC seeks to foster competition in the affected market.
In addition to its upper and lower extremity portfolio, the merged companies will maintain a presence in the growing biologics market. Wright Medical recently obtained FDA approval on the Augment bone graft material (left), which is as an alternative to autograft in a variety of arthrodesis procedures. Tornier has developed a line of biologics that includes its BioFiber line of absorbable scaffolds and its Conexa reconstructive tissue matrix, both of which are used for soft tissue repair.
The U.S. market for cell-based therapies for musculoskeletal injuries (orthobiologics) is valued at over $1.5 billion and is expected to grow significantly in 2016. Other market participants in the orthobiologics space include Dublin, Ireland-based Medtronic (NYSE: MDT), San Diego, California-based NuVasive (NASDAQ: NUVA), Kalamazoo, Michigan-based Stryker (NYSE: SYK), and Johnson and Johnson’s West Chester, Pennsylvania-based DePuy Synthes (NYSE: JNJ). Orthobiologics are part of the growing field of regenerative medicine, which includes bioprinting and stem-cell based therapies, and is projected to be worth $6.5 billion in the U.S. by 2019. Bioprinting, itself, has received recent investment and growth.
Following the merger, the resulting company will be renamed Wright Medical Group, N.V. and will be incorporated and headquartered in the Netherlands.
Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.
According to Medtronic, the MyCareLink Smart Monitor includes a handheld portable device reader paired with a MyCareLink Smart mobile app on a smartphone or tablet. The portable device reader receives pacemaker data (when placed in close proximity to the implanted device), and communicates with the mobile app on a smartphone. The data can then be transmitted to the patient’s physician or clinic (e.g., through cellular or Wi-Fi service). The MyCareLink Smart Monitor also allows patients to create personal profiles on the MyCareLink Connect Website and receive reminders, confirmations, and notifications about their data transmissions. HIT Consultant reports that the MyCareLink Smart Monitor will allow for faster treatment, reduced time in clinical care facilities, and potential improvements in survival rates.
“As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”
Medtronic recently agreed to pay up to $458 million for California-based Twelve, Inc., a privately-held developer of transcatheter mitral valve replacement devices. The terms of the deal include $408 million at closing and $50 million on achievement of CE Marking. The deal is expected to close in October 2015.
Medtronic now joins fellow multi-billion dollar med-tech giants, Edwards Lifesciences and Abbott Laboratories, in the race to stake a claim in the transcatheter mitral valve device space. In July, Edwards paid $400 million for CardiAQ Valve Technologies, a transaction that just recently closed, and Abbott acquired Tendyne Holdings, Inc. for $250 million.
Medtronic presently offers two transcatheter heart valves: “CoreValve Evolut R” for aortic valve replacement and “Melody” for pulmonary valve replacement. Sean Salmon, SVP and President of Medtronic’s Coronary & Structural Heart division stated:
Upon close, this acquisition will strategically augment our existing capabilities in the transcatheter mitral space, which represents an important growth opportunity for Medtronic.
Medtronic’s Coronary & Structural Heart division accounted for nearly $3 billion of the company’s $17 billion FY2014 revenue. The planned acquisition of Twelve suggests that Medtronic seeks to aggressively increase its market-share.
Medtronic PLC recently announced its acquisition of Aptus Endosystems, further adding to its portfolio of medical device products. The acquisition was reported to be valued at approximately $110 million.
According to its website, Aptus Endosystems produces advanced technology for endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Its products are said to secure artificial patches inside weakened aortic arteries, helping to improve a condition known as abdominal aortic aneurysm. These systems are said to be designed for patients whose anatomies may not be ideal for traditional surgical treatment for aneurysms.
Aptus’s website states that its Heli-FX and Heli-FX Thoracic EndoAnchor systems minimize the need for complicated procedures by attaching a variety of aortic endografts to the native vessel wall. The website states that these systems are used to anchor the liner and prevent leakage, and are especially helpful for patients with existing problems with an endograft seal or who are considered high risk candidates for a revision procedure if the initial seal fails.
According to the Aptus website, both systems are approved for distribution in the European Union and are cleared by the FDA for distribution in the U.S. They are said to be compatible with both Medtronic’s Endurant and Valiant graft systems, as well as other commercially available stent grafts.
According to news sources, Medtronic has also acquired several other companies this year including CardioInsight (for $93 million); Dutch diabetes clinic Diabeter; Sophono; and Advanced Uro-Solutions.
On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over allegations that Medtronic had violated the Trade Agreements Act of 1979. The Trade Agreements Act requires that products sold to the U.S. government originate in the United States or in a country that has signed an international trade agreement with the United States.
According to the press release, the government alleged that Medtronic made false statements regarding the origin of medical devices sold to the United States that had originated in China and Malaysia, prohibited countries under the Trade Agreements Act. The specific devices at issue were related to cardiac treatment and spinal surgery.
The Star Tribune quoted Medtronic spokeswoman Cindy Resman as stating that Medtronic “makes no admission that any of its activities were improper or unlawful.”
FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan
This week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic valve replacement device approved for use in replacing a previously implanted artificial valve. The press release explained the need for replacing artificial valves over time:
Some patients whose own aortic valve failed to work properly in the past undergo open-heart surgery to replace the faulty valve with an artificial heart valve. Over time, artificial valves that are made of animal tissue wear out—becoming narrowed, leaky or both—and may need to be replaced again.
The press release notes that prior to this approval, the only option for patients needing to replace an artificial aortic valve was open heart surgery; however, some such patients may not be qualified candidates for open heart surgery. The press release also stated that the CoreValve system can now provide a less invasive alternative for replacing artificial valves, thereby opening the option of subsequent valve replacements to a new category of patients. Medtronic provided data on the CoreValve Expanded Use Study Failed Bioprosthetic Surgical Valve on its website.
According to press releases, the CoreValve system also just received regulatory approval in Japan, in addition to previous regulatory approval in the U.S. and Europe.