FDA gives Edwards ’ Sapien 3 Ultra TAVR the nod
Edwards Lifesciences (NYSE:EW) can now market its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) device in the United States.
The FDA approved the device for severe, symptomatic aortic stenosis patients for whom open-heart surgery is considered an intermediate or greater risk, the Irvine, Calif.-based company said.
For the Ultra, Edwards has added a taller skirt with sizes 20, 23 and 26 mm to the Sapien 3 design to eliminate paravalvular leak and improve TAVR outcomes. The Ultra device also introduces an “on balloon” design that the company said does away with the need for valve alignment during the pro...
Source: Mass Device - December 28, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Food & Drug Administration (FDA) News Well Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news
Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
IRVINE, Calif., Dec. 28, 2018 -- (Healthcare Sales & Marketing Network) -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SA... Devices, Interventional, Cardiology, FDA Edwards Lifesciences, SAPIEN 3 Ultra, transcatheter, aortic valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 28, 2018 Category: Pharmaceuticals Source Type: news
Venus Medtech completes Keystone Heart merger
Chinese transcatheter heart valve maker Venus Medtech said today that it closed its merger with Keystone Heart.
Privately-held Keystone Heart sells TriGuard embolic protection devices that are designed to protect the brain during transcatheter aortic valve replacement and other cardiac procedures.
Hoping for FDA approval in the third quarter of 2019, Keystone Heart is enrolling patients in the U.S. for a trial of its TriGuard 3 product. The company expects to win CE Mark approval for the device by the end of the first quarter in 2019.
“It is of utmost importance to us that our devices improve the quality life of the...
Source: Mass Device - December 26, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Cardiovascular Catheters Featured Mergers & Acquisitions Keystone Heart Venus Medtech Source Type: news
Life-size 3D-printed 'human' primed for radiation therapy
Researchers from Louisiana have created a 3D-printed full-body phantom that...Read more on AuntMinnie.comRelated Reading:
3D printing technique improves heart valve sizing
3D printing gives pediatric heart surgery a boost
3D-printed lungs improve patient understanding of surgery
3D head models reduce workload for brain radiotherapy
3D printing enhances training for cleft lip repair (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 18, 2018 Category: Radiology Source Type: news
Colombia clears Hancock Jaffe first-in-human VenoValve trial
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that it won regulatory approval from Colombia’s INVIMA, the country’s FDA equivalent, to launch a first-in-human trial of its VenoValve device.
The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said.
Hancock Jaffe said it is now making arrangements to export VenoValves into Colombia, as well as to begin screening and enrollment of patients in the study. The company said it will provide a...
Source: Mass Device - December 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves hancockjaffelabs Source Type: news
Abiomed ’s New Collaboration Could Cause Shockwaves in Industry
Abiomed and Shockwave Medical just got a little bit closer. Recently the two companies announced that Danvers, MA-based Abiomed and one of the MDDI 2017 company finalists would be investing about $15 million in Shockwave. In addition, the two firms would be working on a training and education program in the U.S. and Germany focused on the benefits of complementary use of their respective technologies.
Fremont, CA-based Shockwave has developed an intravascular lithotripsy technology that employs sonic pressure waves to safely crack vascular calcium within the vessel wall, which enables arteries to expand under low pressure...
Source: MDDI - December 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Moody ’ s: Outlook strong for medical devices in 2019
The medical device industry should see a stand-out year in 2019, according to a Moody’s report on the industry, Medtech Dive reports.
The financial services company predicts a positive outlook for medtech, with forecasted earnings before interest, tax, depreciation and amortization of between 4.5% and 5.5% for companies on an organic basis, according to the report.
The positive outlook for medtech stands out from the rest of the healthcare field, with pharmaceuticals and U.S. for-profit hospitals only receiving a stable outlook, Medtech Dive reports.
Revenue growth for device companies will be driven through innovation ...
Source: Mass Device - December 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Moody's Investor Service Source Type: news
RNAIII (RIP) & Deriv. as potential tools for the treatment of S. aureus biofilm infections
(Bentham Science Publishers) S. aureus under the biofilm mode of growth is often related to several nosocomial infections, more frequently associated with indwelling medical devices (catheters, prostheses, portacaths or heart valves).The present paper will provide an overview on the activity and potential applications of RIP as biofilm inhibiting compound, useful in the management of S. aureus biofilm infections. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 14, 2018 Category: International Medicine & Public Health Source Type: news
Edwards to add 370 employees in Costa Rica
Edwards Lifesciences (NYSE:EW) is slated to add 370 to its workforce in Costa Rica as part of an expansion plan in the region, according to a post from the Costa Rican Investment Promotion Agency (CINDE).
The Irvine, Calif.-based company originally established its facilities in Costa Rica in 2016, and currently employs 480 employees in the region.
“Edwards Lifesciences continues expanding with Costa Rica, generating new jobs in Cartago and adding value to the medical devices exports. In our country, the company has a high-tech plant for manufacturing cardiovascular valves which are exported worldwide. It is thanks ...
Source: Mass Device - December 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Edwards Lifesciences Source Type: news
Heart valve disease can now be treated without surgery
In 2011, the U.S. Food and Drug Administration (FDA) approved a breakthrough non-surgical heart procedure called Transcatheter Aortic Valve Replacement, or TAVR for short, to replace diseased aortic valves in patients who are too sick to undergo traditional open heart surgery. What made the procedure so revolutionary is that it replaced the damaged valve through a tiny catheter, much like a stent placed in an artery, avoiding major surgery to open the patient ’s chest and replace the old valve.
Today,… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 13, 2018 Category: American Health Authors: Julie LaManna Source Type: news
Boston Scientific touts win in continued TAVR patent spat with Edwards Lifesciences
Boston Scientific (NYSE:BSX) today claimed a win in an ongoing patent spat with Edwards Lifesciences (NYSE:EW) over transcatheter aortic valve replacement system patents.
Marlborough, Mass.-based Boston Scientific said that a jury in the U.S. District Court for the District of Delaware ruled in its favor, finding that their ‘608 patent, related to a transcatheter heart valve sealing skirt, is valid and that Irvine, Calif.-based Edwards Sapien 3 aortic valve infringes on that patent.
The jury determined that Edwards owes Boston Scientific $35 million in infringement damages through to the end of 2016. Damages and i...
Source: Mass Device - December 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Featured Legal News Patent Infringement Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news
Abiomed puts $15m into Shockwave
Abiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies.
Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The company said its catheter is often used in patients with heavily calcified Iliac arteries in order to prepare for the delivery of devices with catheters, like transcatheter heart valves and Abiomed’s Impella heart pump.
“While we are...
Source: Mass Device - December 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Abiomed Shockwave Medical Source Type: news
3D printing technique improves heart valve sizing
Researchers from Harvard University have developed a 3D printing technique...Read more on AuntMinnie.comRelated Reading:
3D-printed aortas could work well for TAVR
'Bitmap' technique enhances quality, speed of 3D printing
3D printing bolsters care for congenital heart disease
Flexible 3D-printed heart replicates size, texture
Rotational angiography is viable for 3D-printed hearts (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 11, 2018 Category: Radiology Source Type: news
Innovative heart procedure will extend lives of patients with faulty heart valve
Up to 400 patients each year are set to benefit from the procedure being made available more widely. (Source: NHS Networks)
Source: NHS Networks - December 11, 2018 Category: UK Health Source Type: news
Predicting leaky heart valves with 3D printing
(Wyss Institute for Biologically Inspired Engineering at Harvard) Researchers at the Wyss Institute have created a novel 3D printing workflow that allows cardiologists to evaluate how different valve sizes will interact with each patient's unique anatomy, before the medical procedure is actually performed. This protocol uses CT scan data to produce physical models of individual patients' aortic valves, in addition to a 'sizer' device to determine the perfect replacement valve size. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 10, 2018 Category: International Medicine & Public Health Source Type: news
