Showing all posts written by Alison Hill
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.
FDA Will Hold Hearing on Communications Regarding Unapproved Uses
The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on communications regarding off-label uses of approved drugs and medical devices.
Currently, the FDA regulates how pharmaceutical and medical device companies can communicate uses of their products through approved labels, but many of those companies believe that greater sharing of information could significantly enhance patient treatments and outcomes. The press release explains that the FDA is aware of technological and business changes that are increasingly affecting medical decision making and prescribing. Such awareness prompted the FDA to review its regulations and policies governing companies’ communications regarding unapproved uses of approved medical products. The Agency anticipates that feedback from the meeting will help inform policy development in this area.
In the press release, specific attention is drawn to the FDA’s heightened interested in comprehensively understanding: how increased communications from companies regarding unapproved uses could impact the public health; how changes in the health care system that give payers and formulary committees more power in prescribing practices incentivize firms to provide more safety and effectiveness data; the impact of increased accessibility of information relating to medical products on companies’ incentives to communicate information about off-label uses; the standards that should apply to off-label communications to minimize the potential of harm; and what factors should be considered when evaluating whether communications regarding unapproved uses are misleading, including what information must be disclosed to ensure consumers are not misled.
In August, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) released guidelines intended to improve communication between biopharmaceutical companies and other health care professionals. Following the FDA’s announcement of the November meeting, Jeff Francer, Vice President and Senior Counsel of PhRMA, issued a statement praising the FDA on its efforts to modernize its regulations surrounding information sharing:
Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system.
Comments will be accepted after the hearing, until January 9, 2017.
Medtronic Acquires HeartWare for $1.1 Billion
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.
FDA Proposes Ban on Powdered Gloves
The U.S. Food and Drug Administration has announced a proposal to ban most powdered medical gloves in the United States due to a health risk posed to patients.
Powder is often added to medical gloves in an effort to make them easier to put on and take off, but aerosolized glove powder on latex gloves can cause serious respiratory allergic reactions. Additionally, powdered synthetic gloves, although not associated with an increased risk of allergic reactions, pose several potential medical complications, including wound inflammation, airway inflammation, and post-surgical adhesions.
According to Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health:
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of. We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
If approved, the ban will apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for surgeon glove lubrication. The ban would not apply to powdered radiographic protection gloves, because the agency is not aware of any such gloves available on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves would also be excluded from the ban.
Prior to the ban proposal, the FDA conducted a thorough review of scientific literature and comments received in response to a February 2011 public inquiry on the topic. The FDA also determined that the ban would be unlikely to impact medical practice due to the wide availability of similar, non-powdered gloves.
The proposed rule is available online for public comment for 90 days.
Stimwave’s Wireless Pain Relief SCS System Receives FDA Clearance
Fort Lauderdale-based company Stimwave Technologies announced today that its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain received FDA 510(k) clearance. The Company plans to begin full nationwide commercialization January 1, 2016.
According to Stimwave, its Freedom-8A Spinal Cord Stimulation (SCS) System is the world’s first fully-programmable wireless SCS neuromodulation device that eliminates the need for painful tunneling and internal battery placement within the body. Stimwave states that its device features a compact 0.4 cc profile and eight electrodes placed near nerve fibers around the dorsal aspect of the spinal column. The device is said to deliver selected pulses of energy to the electrodes to alter the transmission of pain signals to the brain. Additionally, Stimwave notes that its device is implanted in an outpatient setting through a standard needle, eliminating the need for general anesthesia or a large surgical incision.
Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of Pain Wise, stated:
“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features, polarity selection options for up to eight separate electrodes per device, in the body in the least invasive fashion ever offered. This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”
According to the press release, Stimwave is currently investigating the safety and efficacy of even wider programmability options, such as high-frequency programming up to 10,000 Hz, in an FDA approved clinical trial.
Zyga Receives 510(k) Clearance
Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its SImmetry® Sacroiliac Joint Fusion System using either a two-incision or a single-incision technique. The SImmetry System uses a minimally invasive surgery procedure and is designed to stabilize the sacroiliac joint.
David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine, stated:
In the operating room, surgeons need as many options as possible to effectively treat each individual. . . . This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.
The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability of adults in the U.S. Accordingly, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive sacroiliac joint fusion, improving patient access to the procedure.
Southern Spine Announces 2015 MDEA Honor for StabiLink® MIS Spinal Fixation System
Southern Spine announced today that StabiLink® MIS Interlaminar Spinal Fixation System has been chosen as the Silver Winner in the Implant and Tissue Replacement category of the 18th Annual Medical Design Excellence Awards competition.
According to the press release, a benefit of the StabiLink® MIS Interlaminar Spinal Fixation System is that the implant is positioned between the spinous processes, away from the spinal cord and spinal nerves. The press release states that the implant is placed through a 2-4 cm incision using the PG® Precision Guided Inserter/Compressor, an All-in-One instrument that permits the surgeon to quickly and accurately place the implant with or without removal of the interspinous ligaments. According to the press release, the PG®Inserter/Compressor eliminates the need for multiple, “bulky” compressors and reduces overall procedure time. The press release further states that the StabiLink® implant may lead to significant benefits for patients, including less pain, reduced operative time, less blood loss, and reduced length of hospital stay compared with those undergoing more invasive procedures involving the use of more traditional pedicle screws and rods.
The press release references U.S. Pat. Nos. 8,419,738, 8,591,547, and 8,623,024 which list an assignee of Southern Spine, LLC on the cover pages of the patents.
David C. Field, CEO of Southern Spine, LLC, stated: “As a small innovative company competing with multi-billion dollar corporations, we appreciate being considered and recognized by MDEA. Our StabiLink® MIS Interlaminar Spinal Fixation System was a collaboration between design, engineering, regulatory and experienced surgeons to produce a unique system that offers the ‘Best First Option’ for many patients.”
FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System
St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads, which have received MR-conditional labeling for use with the Protégé MRI system for chronic pain treatment. According to the press release, the Protégé MRI system is the world’s smallest available MR-conditional SCS implantable pulse generator, as well as the only device to allow patients to safely undergo head and extremity MRI scans. Additionally, the press release states that it is the only device to offer software upgrades as an alternative to surgical device replacement.
“With the approval of the Protégé MRI system, St. Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology,” said Dr. Eric Fain, group president of St. Jude Medical.
The press release notes that SCS therapy can offer proven chronic pain relief for many patients while reducing or even eliminating the use of pain medication. According to the press release, spinal cord stimulation therapy utilizes a small implanted generator to deliver electrical impulses to the nerve fibers of the spinal column via thin wires, or leads, with electrodes; the electrical pulses reduce the sensation of pain by masking or interrupting pain signals travelling up the spinal cord to the brain.
St. Jude Medical has also stated that it plans to seek updated labeling for several existing products, including the Penta™ paddle lead, to enable more patients to safely undergo MRI scans. The company also indicated that it plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.
Apple’s ResearchKit Turns iPhones into Medical Devices
Apple recently released ResearchKit, an open-source software platform that allows scientists to gather medical data using an individual’s own iPhone. According to The Asian Age, the new platform allows iPhone users to easily and voluntarily join medical research studies while deciding how their data is shared with researchers.
ResearchKit enables researchers to learn about a patient’s gait, motor impairment, fitness, speech, and memory by accessing the iPhone’s built-in sensors (e.g., accelerometer, microphone, gyroscope and GPS sensors). The new software builds on Apple’s HealthKit software, which was announced last year. HealthKit allows applications that provide health and fitness services to share their data with HealthKit and with each other. With the release of ResearchKit, users will be able to send data gathered through the HealthKit application, such as information on blood pressure, weight, blood glucose levels, and exercise habits, to medical researchers partnering with Apple.
Jeff Williams, Apple’s Senior Vice President of Operations, said:
With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research.
Several research institutions, such as Stanford University School of Medicine and Weill Cornell Medical College, have already partnered with Apple to create software applications for ResearchKit for use in clinical studies on asthma, heart disease, diabetes, and Parkinson’s disease.
Essential Medical, Inc. Successfully Completes First in Man Studies for MANTA Large Bore Vascular Closure Device
Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a device designed to seal 18F large bore femoral punctures.
According to the press release, the MANTA devices were deployed in less than one minute in each of five patients, achieving hemostasis at the large bore puncture site with exceptional clinical, angiographic and hemodynamic success in all patients. The press release also indicated that none of the patients showed evidence of hematoma, and all patients were discharged the next day.
Essential Medical stated that Dr. Gary Roubin, MD, PhD, a leading interventional cardiologist, performed the first two cases. Dr. Roubin remarked:
“In interventional cardiology it’s critical to define the problem that the patient is facing, solve the problem and use the best clinical science available to confirm beneficial outcomes. We’re doing that with MANTA and it promises to be a truly transformative technology for providing percutaneous access for large bore therapeutic devices.”
According to Essential Medical, MANTA seals femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA), employing sealing components similar to the Company’s other closure device, X-Seal, which received CE mark approval last month, and is said to be indicated for smaller punctures for angiography, angioplasty, and stenting.
Essential Medical indicates that large bore femoral access has been associated with bleeding complications, the need for transfusions, increased hospital costs, and patient discomfort and disability. Dr. Lawrence Garcia, Chief of International Cardiology at St. Elizabeth’s Medical Center in Boston, also participated in the study and stated that the device satisfies a “critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels.”
Greg Walters, founder and CEO, states in the announcement that Essential Medical seeks to commence a CE-marketing study of the MANTA device in early 2015.