FDA ramps up scrutiny of materials in medical devices
(Image by Michael Longmire on Unsplash)
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.
It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series rip...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news
FDA Wants to Take a Hard Look at Medical Device Materials
As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.Â
The agency released a statement Friday from Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health that addresses recent advances in materials science and how these advances have impacted the safety of medical devices.
"Materials used in today's medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these," Gottlieb and ...
Source: MDDI - March 15, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Materials Regulatory and Compliance Source Type: news
FDA Approves New Indication for Valve Repair Device to Treat Certain Heart Failure Patients with Mitral Regurgitation
SILVER SPRING, Md., March 14, 2019 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitat... Devices, Interventional, Cardiology, FDA Abbott Vascular, MitraClip, mitral valve, mitral regurgitation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 14, 2019 Category: Pharmaceuticals Source Type: news
Neovasc advances warrant exchange from CardiAQ case
Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve.
The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it issued in November 2017 to cover the $42 million balance from its loss in the CardiAQ lawsuit. The deals call for Neovasc to issue more than 496,000 shares in exchange for nearly 58.4 million warrants, which works out to 0.0085 shares per warrant.
“We are delighte...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Legal News Replacement Heart Valves Wall Street Beat neovasc Source Type: news
Edwards Makes Significant Moves in the Mitral Valve Space
Edwards Lifesciences bolstered its presence in the mitral valve space through a pair of transactions it announced Monday. The Irvine, CA based company invested $35 million in an exclusive right to acquire Corvia Medical and in addition the firm obtained certain assets of Mitralign for an undisclosed sum.
Edwards investments come on the heels of Boston Scientific exercising its option to acquire the remaining shares of Millipede Inc. for $325 million. In addition, the Marlborough, MA-based company said a $125 million payment becoming available upon achievement of a commercial milestone.
Tewksbury, MA-based Corvia Medical&ac...
Source: MDDI - March 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Edwards Lifesciences gets in on Corvia, Mitralign
Edwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.
Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.
“We ...
Source: Mass Device - March 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Mergers & Acquisitions Replacement Heart Valves Edwards Lifesciences Source Type: news
FDA Slammed for & #039;Hiding & #039; Device-Related Injury Reports
An investigative report claims FDA is hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program.
Kaiser Health News reported that at least 1.1 million incidents have been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE. The Kaiser report focuses on the obscurity of the practice, which was created nearly 22 years ago, as MD+DI reported at the time.
Back in 1997, FDA urged manufacturers of 12 types of medical devices to request permission to submit only summary ...
Source: MDDI - March 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Report: FDA hiding millions of adverse event reports from docs, public
The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News.
Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the report.
The summary reporting repository was originally created as an alternative for issues “well-known and well-documented with the FDA” and covers approximatel...
Source: Mass Device - March 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
A New Way of Looking at Things
It can get pretty crowded in an interventional procedure room, specifically for those places where image-guided therapy is being conducted. “Some of these procedures may require upwards of 15—or sometimes even 20—people in the suite,†said Barry T. Katzen, MD, founder and chief medical executive of Miami Cardiac & Vascular Institute, part of Baptist Health South Florida, in an interview with MD+DI. “And all of them have certain needs for technology, for space, for visualization, and things like that.â€
He noted th...
Source: MDDI - March 4, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Imaging Source Type: news
New joint Position Statement published on safe treatment of hyperprolactinaemia
The paper,“Echocardiography and monitoring patients receiving dopamine agonist therapy for hyperprolactinaemia: A joint position statement of the British Society of Echocardiography, the British Heart Valve Society and the Society for Endocrinology” was published today in bothClinical Endocrinology andEcho Research and Practice.This joint statement, written collaboratively by the key Societies with an interest in this condition, is important reading for any general medical professionals, as well as those in the cardiovascular and endocrine fields, that are involved in managing patients with hyperprolact...
Source: Society for Endocrinology - March 1, 2019 Category: Endocrinology Source Type: news
Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.
The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.
Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.
Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
LivaNova shares dip despite Q4, 2018 earnings beat
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker posting fourth quarter and full year 2018 earnings that topped expectations on Wall Street.
The London-based company posted losses of $210.6 million, or $4.34 per share, on sales of $297 million for the three months ended December 31, seeing losses grow 88.5% while sales grew 6.7% compared with the same period during the previous year.
Adjusted to exclude one-time items, earnings per share were $1.12, just ahead of the $1.10 consensus on Wall Street where analysts expected to see sales of $295 million, which the company topped.
For the full year, L...
Source: Mass Device - February 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
Aortic calcification: An early sign of heart valve problems?
Aortic valve calcification is a condition in which calcium deposits form on the aortic valve in the heart. These deposits can cause narrowing at the opening of the aortic valve. This narrowing can become severe enough to reduce blood flow through the aortic valve -- a condition called aortic valve stenosis. Aortic valve calcification may [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - February 26, 2019 Category: Databases & Libraries Source Type: news
Medical News Today: Study ties arthritis pain reliever to heart valve disease
An analysis of 8,600 electronic medical records has found a specific link between the use of the NSAID celecoxib (Celebrex) and aortic stenosis. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 26, 2019 Category: Consumer Health News Tags: Osteoarthritis Source Type: news
What do you know about heart murmurs?
Heart murmurs are sounds during your heartbeat cycle -- such as whooshing or swishing -- made by turbulent blood in or near your heart. These sounds can be heard with a stethoscope. A normal heartbeat makes two sounds like "lubb-dupp" (sometimes described as "lub-DUP"), which are the sounds of your heart valves closing. Heart murmurs [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - February 25, 2019 Category: Databases & Libraries Source Type: news
