Blog Tag: FDA Approval
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.
Medtronic’s MiniMed 670G system was recently approved by the FDA – this marks the first-ever FDA approval of a hybrid closed-loop insulin delivery system. Medtronic explains that the system uses a computer algorithm in combination with a wearable glucose monitor that automatically measures glucose levels every five minutes after which it automatically administers any insulin needed by the patient. While the system does not completely automate insulin management—users still have to enter mealtime carbohydrates and must periodically calibrate the sensor, among other tasks—nevertheless, Lori Laffel, an endocrinologist at Harvard University’s Joslin Diabetes Center, says that the approval was a “big step forward.”
According to Medtronic, the MiniMed 670G system features Medtronic’s SmartGuard HCL algorithm and new Guardian Sensor 3, which can be worn continuously for up to seven days. The system is approved for the treatment of type 1 diabetes in individuals fourteen years of age or older and provides continuous delivery of basal insulin (at rates selectable by the user) and administers insulin boluses (in amounts that can also be adjusted by the user). According to the U.S. Centers for Disease Control and Prevention, approximately 5% of people with diabetes have type 1 diabetes, which is also commonly referred to as “juvenile diabetes.”
With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes—particularly for minimizing glucose variability and maximizing time in the target range.
Following Medtronic’s recent approval, experts and analysts have also opined on what future insulin delivery systems could provide. For example, Aaron Kowalski, PChief Mission Officer and Vice President of Research at JDRF, an organization dedicated to type 1 diabetes research, states:
This is a fantastic step forward, but we are not done, JDRF will continue supporting other artificial pancreas advancements and advocating for broad access to this life-changing technology. Next generation systems are in the pipeline that could provide even better outcomes with less burden.
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new report issued by the NEST Planning Board. The Planning Board was convened by the FDA and the Duke-Margolis Center for Health Policy in order to outline the initial priorities for NEST.
The FDA plans for NEST to be the national evaluation system for medical devices and is aiming to evaluate evidence from the entire life-cycle of medical device products in order to more effectively monitor medical device safety and efficacy.
In July, FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health (CDRH) stated that this system for evaluating health technology:
could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
The Planning Board’s report explains that new standards for sharing medical data between multiple entities will be the focus of a planned NEST Coordinating Center. The proposed Coordinating Center will work to develop a network of experts which will aid NEST in collecting and evaluation clinical data, as well as data received directly from patients. According to the report, the Coordinating Center will foster the development of a NEST clearinghouse of analytical tools, methods, and standards for using linked real-world data collected through clinical and administrative workflows as well as from patients themselves to evaluate devices.
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 U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software changes to the FDA for approval. The final document will provide assistance to medical device companies and the FDA for determining when changes to software or firmware for a medical device require FDA clearance. The medical devices covered include 510(k)-cleared devices and preamendments devices subject to 510(k).
The FDA’s proposed guidance explains that premarket notifications are generally submitted for commercially-distributed medical devices undergoing significant changes in design. Such changes include modifications that “could significantly affect the safety or effectiveness of the device” or a “major change or modification in the intended use of the device.” The proposed guidance relates to software changes and is an update to the original guidance issued in 1997 regarding changes to existing devices.
The “software” subject to the proposed guidance is defined as “electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.” This includes software embedded in a device, software that is an accessory to another device, and “software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”
The FDA provides a flow chart for assisting with the determination, see below. Issues addressed in the determination include changes related to: strengthening cyber security; meeting specifications of the most recently cleared device; introducing or affecting hazardous situations; creating new risk control measures; and affecting clinical functionality or intended use of the device. Additional factors to consider beyond those in the flow chart and some examples of modifications are provided in the draft guidance as well.
The proposed guidance notes that in some cases a new 510(k) is not necessary, and that existing Quality System (QS) requirements may suffice. Such QS requirements mandate, among other things, that the manufacturer maintains records, for production upon request, regarding such changes and the processes used to determine the changed device meet the design specifications. Further, the proposed guidance does not apply to software for which the FDA has previously said it will not enforce compliance, including some mobile apps used with medical devices.
Some observers think the proposed guidance will help with improving cybersecurity of connected medical devices. The public may provide comments to the FDA on the proposed guidance until November 7, 2016: comments may be submitted electronically here.
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.
On June 14, 2016, the U.S. Food and Drug Administration approved AspireAssist, an obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal. According to a press release by the manufacturer Aspire Bariatrics, the AspireAssist System is an endoscopic alternative to weight loss surgery for people with moderate to severe obesity and is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
The FDA news release summarized the procedure of installing and using AspireAssist as follows:
To place the [AspireAssist] device, surgeons insert a tube in the stomach with an endoscope via a small incision in the abdomen. A disk-shaped port valve that lies outside the body, flush against the skin of the abdomen, is connected to the tube and remains in place. Approximately 20 to 30 minutes after meal consumption, the patient attaches the device’s external connector and tubing to the port valve, opens the valve and drains the contents. Once opened, it takes approximately five to 10 minutes to drain food matter through the tube and into the toilet. The device removes approximately 30 percent of the calories consumed.
According to the FDA news release, the FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy and 60 control patients who received only the lifestyle therapy. The lifestyle therapy included nutrition and exercise counseling. After one year, patients who used AspireAssist lost an average of 12.1 percent of their body weight compared to 3.6 percent for the control patients. Clinical trial results also suggested that both patient groups had small improvements in conditions often associated with obesity, such as diabetes, hypertension and quality of life.
A youtube video on the AspireAssist System published by Aspire Bariatrics is attached below:
The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC). The Times reports that while the test may not be perfect, it was able to produce results that generally agree with those of an invasive tumor biopsy. NSCLC is recognized as the most common form of lung cancer, accounting for approximately 85% of all detected lung cancers. Therefore, the market for Roche’s test is likely robust.
Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients. Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.
The FDA specifically identified that Roche’s liquid biopsy can now be used as a blood-based companion diagnostic for Genetech’s cancer drug Tarceva (erlotinib), which was approved in 2013 as a first-line treatment for patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or L858R substitution mutations, the same genetic mutations identified by Roche’s new test.
Medical professionals appear accepting of the new technology and excited regarding the role it could fill in patient treatment – Dr. Benjamin Levy, MD, Director of Thoracic Medical Oncology at Mount Sinai Health Systems and Hospital said:
The advent of liquid diagnostic platforms in non-small cell lung cancer is truly a game changer in the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple minimally invasive test that can subsequently inform treatment decisions is a win for both physician and patient.
Swiss biotech company Roche announced on December 21, 2015 that the FDA has approved the Cobas® 6800 and 8800 Systems from its Pleasanton, California-based Roche Molecular Diagnostics (RMD) for the Cobas® HIV-1 viral load test.
According to the announcement, Cobas® HIV-1 is an in vitro nucleic acid amplification test for quantifying human immunodeficiency virus type 1 (HIV-1) in HIV-1-infected individuals. According to Paul Brown, Head of Roche Molecular Diagnostics:
“The cobas® HIV-1 test is based on Roche’s unique dual-target technology to simultaneously amplify and detect two separate regions of the HIV-1 genome, which are not subject to selective drug pressure. The addition of this test on the fully automated cobas® 6800/8800 Systems provides laboratories with a comprehensive virology menu to support physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.”
According to Roche, the cobas® 6800 and 8800 Systems are automated molecular testing systems in the areas of donor screening, viral load monitoring, women’s health and microbiology. Roche states that the systems are based on Nobel-prize winning PCR technology and can process 384 results for the 6800 System and 960 results for the 8800 System in an eight-hour shift, with up to 96 results within the first 3.5 hours.
FDA previously approved the two systems for viral load tests for hepatitis B (Cobas® HBV) and hepatitis C (Cobas® HCV) in October 2015 . According to the press release, Roche plans to expand the menu to include a viral load test for cytomegalovirus (CMV) and other quantitative assays.
The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency reclassified mesh products designed and marketed for transvaginal treatment of POP as Class III “High Risk Devices.” Second, the FDA will now require manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The new orders may be in response to suits filed by women injured by transvaginally placed polypropelene mesh products against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. Under the new orders, the agency will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation. Particularly, the PMA process will require manufacturers of transvaginally placed POP mesh to prove their products are both safe and effective for use in the public. For devices that are already in the market, manufacturers will have thirty months to submit a PMA as required by federal law. For new surgical mesh devices, manufacturers must submit a PMA before those devices can be approved for marketing. Through the PMA process the FDA will determine if these products should be removed from the market. Even if the products are allowed to remain in the market, the FDA could require stricter warning labels.
Previously, the FDA issued safety warnings to doctors and patients about the use of surgical mesh for transvaginal POP repair in 2008 and 2011. The agency also convened an advisory panel to determine actions to take regarding transvaginal surgical mesh in 2011, and ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to transvaginal surgical mesh devices in 2012. In 2014, the FDA had even issued two proposed orders to reclassify the devices from class II to class III in order to require manufacturers to submit a PMA application instead of submitting to the less stringent 510k) approval process.
According to the orders, the announced FDA actions only apply to mesh devices marketed for the transvaginal repair of POP. Surgical mesh devices for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP, are excluded from these orders.
Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies damaged by tumors, fractures, or osteomyelitis.
According to NuVasive’s FDA filing, the X-Core Mini system can also be used for reconstruction following a corpectomy or to restore the integrity of the spinal column without resorting to spinal fusion in patients that have short life expectancies due to advanced-stage tumors involving the cervical spine. The X-Core Mini system is available in a variety of sizes and shapes to accommodate differences in individual patients’ physical characteristics and pathology.
NuVasive states that the X-Core Mini must be used with supplemental fixation that has previously been cleared by the FDA for use in the cervical spine, which includes NuVasive’s new Archon Reconstruction Corpectomy plate. This plate is designed to increase rigidity and to resist screw pullout.
The assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers. Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine.
According to Fierce Medical Devices, NuVasive became the third-largest competitor in the spinal device market last year. NuVasive maintains an active patent portfolio to help protect its market share: the USPTO Assignment Database lists NuVasive as the Assignee of 325 patents and patent applications dating from 1999 to the present.
By: Mark Speegle
(May 26, 2015) VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System. This approval comes after a successful 470 patient IDE study of the Superion system. VertiFlex’s press release highlighted the following results from the IDE study:
- Largest, most robust IDE device trial for moderate lumbar spinal stenosis
- Superion demonstrated clinical success of >80% in all major components of the composite primary endpoint at 24 months, maintaining durability of effect through 36 months
- Superion patients exhibited similar leg pain improvement, as measured by VAS, compared to published literature on open surgical decompression
- Healthcare economic data was captured, demonstrating Superion’s cost-effective equivalency to open surgical decompression
The press release also notes that Superion has already been successfully implanted in more than 2,000 patients internationally. VertiFlex was founded in 2005 and is based in San Clemente, CA.
The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. According to the FDA’s News Release, the new rules are “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.” The guidance document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) also includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
The new rules and recommendations are based on draft proposals that the FDA released in 2011 for public comment. The rules’ issuance follows the news of the deaths of two patients from “superbug” infections that have been linked to reusable medical scopes. Olympus, the manufacturer of the implicated scopes, is being sued for failing to issue updated cleaning instructions after a recent redesign, and for selling a “defective scope,” among other allegations.
The FDA’s new rules will only apply to new devices receiving FDA approval, not to devices that are currently on the market. The New York Times reported that “Officials acknowledged that they could only recommend — not require — that products on the market use the more rigorous testing.”
The FDA has said that that the new rules incorporate new testing requirements intended to make reprocessing reusable medical devices more effective. For example, manufacturers will be required to submit data to show that their reusable medical devices, such as duodenoscopes, endoscopes, and bronchoscopes, can be properly disinfected. Manufacturers had previously been required to collect this data, but were not required to submit it to the FDA.
According to the FDA’s press release, the guidance document further “recommends that manufacturers consider reprocessing challenges early in device design.”
The new catheter provides a unique bendable irrigated catheter tip that allows the catheter to better conform to the cardiac anatomy and more effectively form lesions during operation. According to St. Jude Medical, the FlexAbility catheter also has an improved handle and shaft that enhance maneuverability, allowing electrophysiologists to reach challenging anatomical locations with less hand fatigue.
St. Jude’s new catheter could provide benefits to an estimated 10.4 million people in the United States who suffer from some type of cardiac arrhythmia. According to Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute:
“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today. For the past several years we’ve been looking for a catheter that provided a gentler, more optimal approach to ablation. The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients”
MarketWatch reports that the FDA approval of the FlexAbility catheter, which received its CE Mark in Europe last year, bolsters St. Jude Medical’s expanding ablation portfolio, which includes various patents such as U.S. Pat. No. 8,790,341, and expands the ability of physicians to treat patients battling abnormal heart rhythms.
The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices. The same charges were also brought against VSI. According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.
According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins. As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.
The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.
Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.” The case is now pending in the U.S. District Court for the Western District of Texas.