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Dental Work Tied to Heart Infections in People With Artificial Valves Dental Work Tied to Heart Infections in People With Artificial Valves
Invasive dental procedures may raise the risk of rare but serious infections in people who have prosthetic heart valves, a recent French study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 15, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Dental work tied to heart infections in people with artificial valves
(Reuters Health) - Invasive dental procedures may raise the risk of rare but serious infections in people who have prosthetic heart valves, a recent French study suggests. (Source: Reuters: Health)
Source: Reuters: Health - September 14, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

AtriCure launches AtriClip Pro-V in the US
AtriCure (NSDQ:ATRC) said today it launched its AtriClip Pro-V left atrial appendate exclusion system in the US. The newly launched AtriClip Pro-V is designed to be placed through a minimally-invasive surgery and features an open-ended design and tip-first closure mechanism for easier navigation, the Mason, Ohio.-based company claims. “Development of the AtriClip Pro-V is another step in the direction of a comprehensive strategy for management of the left atrial appendage. It expands the options for minimally invasive approaches including right chest access and an easier implantation of an epicardial atrial appe...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves AtriCure Inc. Source Type: news

NeoVasc shares surge 45% on affirmed Tiara patent case decision against Edwards
Neovasc (NSDQ:NVCN) saw its shares jump 45% today after a federal appeals court upheld a district court ruling in a trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve, affirming a decision not to enjoin its Tiara program. With the decision, Neovasc will be required to pay the full judgement of approximately $112 million to Edwards, of which the company said $70 million is already held in an escrow account. The Vancouver-based company said that “there are no other monetary damages arising from the award,” and announced that it will remain the joint inventor of its &lsqu...
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Legal News Replacement Heart Valves Neovasc Inc. Source Type: news

NaviGate touts 1st 52mm transcatheter tricuspid valve procedure
NaviGate Cardiac Structures touted this week that its Gate catheter-guided tricuspid atrioventricular valved stent was implanted six weeks ago into a patient’s transplanted heart. The patient’s transplanted heart was failing due to severe tricuspid valve insufficiency. The successful implantation at the Policlinico of the University of Padua, Italy, is the first European-based patient treated with the company’s tricuspid replacement heart valve. Three hours after the procedure, the patient was showing improved renal function, NaviGate reported. Two months after the intervention, the 67-year-old male patie...
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Implants Cardiovascular NaviGate Cardiac Structures Inc Source Type: news

Viagra Won't Help, and May Harm, Patients With a Heart Valve Disorder
Title: Viagra Won't Help, and May Harm, Patients With a Heart Valve DisorderCategory: Health NewsCreated: 8/29/2017 12:00:00 AMLast Editorial Review: 8/30/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - August 30, 2017 Category: Cardiology Source Type: news

Study: Viagra may harm, not help, patients with heart valve disorder
New research suggests Viagra (sildenafil) might raise patients' risk of " pulmonary hypertension linked to valvular heart disease. " (Source: Health News - UPI.com)
Source: Health News - UPI.com - August 30, 2017 Category: Consumer Health News Source Type: news

Viagra May Harm Patients With Heart Valve Issue
Earlier data suggested the drug might ease high blood pressure in lungs, but new study refutes that (Source: WebMD Health)
Source: WebMD Health - August 29, 2017 Category: Consumer Health News Source Type: news

Viagra Won't Help, and May Harm, Patients With a Heart Valve Disorder
TUESDAY, Aug. 29, 2017 -- When one of the heart's valves goes awry, this can lead to dangerously high blood pressure in the nearby lungs. Recent studies have suggested that the impotence drug Viagra (sildenafil) might help ease the problem, known... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 29, 2017 Category: General Medicine Source Type: news

Which TAVR patients are at risk for hospital readmission?
(University at Buffalo) As more elderly patients undergo the minimally invasive heart valve procedure called Transcatheter Aortic Valve Implantation (TAVR), concerns have been raised as to what causes some to be readmitted for heart failure after the procedure. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 25, 2017 Category: International Medicine & Public Health Source Type: news

Death rates from rheumatic heart disease falling since 1990
(Institute for Health Metrics and Evaluation) The risk of dying from rheumatic heart disease, a condition of damaged heart valves caused by bacterial infection that leads to rheumatic fever, has dropped around the world over the last 25 years, according to a new scientific study published today in The New England Journal of Medicine. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - August 23, 2017 Category: International Medicine & Public Health Source Type: news

Bristol scientists to study oral bacteria that cause heart valve infection
Scientists at the University of Bristol are investigating how bacteria in our mouth can cause a heart problem, called infective endocarditis. Although uncommon, infective endocarditis is a serious condition that can often be fatal. (Source: University of Bristol news)
Source: University of Bristol news - August 21, 2017 Category: Universities & Medical Training Tags: Health, International, Grants and Awards, Research; Faculty of Health Sciences, Faculty of Health Sciences, Bristol Dental School; Press Release Source Type: news

BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency due to the congenital bicuspid aortic valve malformation in which the aortic valve forms with only 2 functional valve leaflets instead of 3. Bicuspid aortic valve malformations affect up to 2% of the population and carry a signi...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves BioStable Science & Engineering Source Type: news

Next-gen Repositionable Self-expanding Catheter Safe for Severe Aortic Stenosis Next-gen Repositionable Self-expanding Catheter Safe for Severe Aortic Stenosis
The self-expanding, repositionable Evolut R transcatheter heart valve (THV) from Medtronic appears safe and effective for treating older patients with severe aortic stenosis, according to a company-funded observational study.Reuters Health Information (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 14, 2017 Category: Consumer Health News Tags: News Source Type: news

Gene editing brings pig organ transplant closer
Conclusion This promising research shows that it can be possible to use gene editing techniques to eliminate retroviruses from pigs, removing one of the potential barriers to using genetically modified pigs as organ donors for humans. There are a few points to note. As the researchers say, though they have shown that pig retroviruses can be passed onto human cells in the laboratory, we don't know what the effects would be in real life. We don't know whether pig retroviruses would be transferred to humans and whether they could cause cancers or immunodeficiency illnesses, for example. The research is at an early stage. The ...
Source: NHS News Feed - August 11, 2017 Category: Consumer Health News Tags: Genetics/stem cells Source Type: news

Abbott launches trial of transcatheter tricuspid repair device, eyes CE Mark
Abbott (NYSE:ABT) said today it enrolled the 1st patient in a clinical trial of a minimally invasive, clip-based transcatheter valve repair system for treating patients with severe tricuspid regurgitation, looking to eventually support CE Mark approval in the European Union. The 1st patient in the trial was enrolled at the Abbott Northwestern Hospital by Dr. Paul Sorajja of the Minneapolis Heart Institute, the Abbot Park, Ill.-based company said. The transcatheter tricuspid valve repair system is built off of technology which has been tested with the company’s MitraClip system, designed to treat mitral valv...
Source: Mass Device - August 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Source Type: news

Abbott Leads Way in First Clinical Trial of Minimally Invasive Clip-based Repair System for Leaky Tricuspid Heart Valves
-Trial will study efficacy and safety of a new transcatheter clip-based repair system for tricuspid valve disease, an undertreated, life-altering condition (Source: Abbott.com)
Source: Abbott.com - August 9, 2017 Category: Pharmaceuticals Source Type: news

Aum Cardiovascular gets permission to start using heart monitoring device
Northfield-based Aum Cardiovascular said Tuesday it's received permission from the U.S. Food and Drug Administration to start selling a handheld digital stethoscope that pairs with an artificial-intelligence system to help medical experts look for signs of heart murmurs in patients with chest pain. The Star Tribune reports on the approval and Aum's plans for the device, called Cadence, which can identify sounds associated with issues such as heart valve disease, congestive heart failure and obstructive… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 9, 2017 Category: Pharmaceuticals Authors: Patrick Rehkamp Source Type: news

LivaNova wins CMS NTAP reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless aortic heart valve replacement won approval from the Centers for Medicare and Medicaid Services for a New Technology Add-On Payment. The London-based company said that the Perceval valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies. With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said. “We are pleased ...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) LivaNova Source Type: news

UPDATE: CMS passes NTAP reimbursement for LivaNova ’ s Perceval, Edwards Intuity aortic valves
Updated to include that the CMS NTAP also covered Edwards Lifescience’s Intuity suturless aortic valve The Centers for Medicare and Medicaid Services today released its Final Rule for FY2018 Medicare Inpatient Payment and Policy, granting New Technology Add-On Payment reimbursement for rapid deployment valves, including LivaNova‘s (NSDQ:LIVN) Perceval and Edwards Lifesciences‘s (NYSE:EW) Intuity aortic valves. London-based LivaNova said that the Perceval sutureless valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technol...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Edwards Lifesciences LivaNova Source Type: news

Avalus Surgical Heart Valve Gains US, European Approval Avalus Surgical Heart Valve Gains US, European Approval
Medtronic announced today that its surgical aortic valve Avalus has received FDA approval and the European CE Mark for the treatment of aortic-valve disease.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 2, 2017 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Medtronic wins FDA nod, CE Mark for Avalus aortic valve
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease. The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central regurgitation. The valve also features interior-mounted leaflet and frame design for improved durability and a low-profile design with a streamlined valve holder and single, one-cut release for easier implantations, Medtronic said. “Medt...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Medtronic touts reduced costs, rehospitalizations in cryoballoon vs RF AF ablation trial analysis
Medtronic (NYSE:MDT) today released data from a health economic analysis from the Fire And Ice trial comparing its Arctic Front cryoballoon catheter to its ThermoCool radiofrequency ablation cath, touting that cryoballoon treatment could reduce costs and rehospitalizations when used to treat paroxysmal atrial fibrillation. Economic analysis results from the trial were published today in the Journal of the American Heart Association. Researchers analyzed data from the 769-patient trial, which Medtronic claims is the largest to compare cryoballoon ablation to point-by-point RF ablation for treating paroxysmal AF, o...
Source: Mass Device - August 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Medtronic Source Type: news

Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Toronto baby boy born healthy after surgery in the WOMB
On May 23, Sebastian was born pink and screaming in Toronto's Mount Sinai Hospital - days after undergoing groundbreaking surgery on his heart valves while he was still in the womb. (Source: the Mail online | Health)
Source: the Mail online | Health - July 26, 2017 Category: Consumer Health News Source Type: news

Anticoagulants for Pregnant Women With Mechanical Heart Valves Anticoagulants for Pregnant Women With Mechanical Heart Valves
While vitamin-K antagonists are usually used to treat patients with mechanical heart valves, they are teratogenic. Can they be used safely in pregnancy, and are there better alternatives?European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 19, 2017 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22. Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round. The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Is this the key to rapidly manufacturing heart valves?
[Image from Wyss Institute at Harvard University]Nanofiber fabrication may be the key to rapidly manufacturing heart valves with regenerative and growth potential, according to new research from Harvard University’s Wyss Institute for Biologically Inspired Engineering. A research team led by Kevin Kit Parker created a valve-shaped nanofiber network that replicates the mechanical and chemical properties of the native valve extracellular matrix (ECM). They used the Parker lab’s proprietary rotary jet spinning technology that was essentially a rotating nozzle that thrust an ECM solution into the nanofibers. T...
Source: Mass Device - July 13, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Prosthetics Replacement Heart Valves Research & Development Harvard University MedTech Wyss Institute for Biologically Inspired Engineering Source Type: news

Study: TAVR, surgical AVR results similar at 2 years in intermediate risk patients
Transcatheter and surgical aortic valve procedures were shown to have similar outcomes at 2 years in severe aortic stenosis patients deemed to be at intermediate surgical risk, according to a recently published study. Data came from a 2-year follow up with patients in the Partner 2 trial, which aimed to explore the difference between the 2 procedures in intermediate risk patients. A total of 2,032 patients were examined in the trial, which was randomly divided into 2 cohorts, with the 1st receiving Edwards Lifesciences‘(NYSE:EW) Sapien XT and the 2nd receiving a surgical AVR procedure. At 2 years, both disease-s...
Source: Mass Device - July 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure. “Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreV...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Finn ’s heart: A journey into the unknown
Three-year-old Finn stands in front of the full-length mirror in his parents’ room, with his shirt off. “Mommy, look how cool!” he shouts, placing his finger along the long scar running down the middle of his chest. “That’s where I had my heart surgeries!” “That’s right, buddy,” Jenna replies, surprised because they’d never talked about his scars. “We always tell him he has a special heart. We don’t ever want him to feel different.” Finn runs off to play. It makes Jenna smile and sometimes cry to see her son so happy and full of life. Now 5 years...
Source: Thrive, Children's Hospital Boston - July 7, 2017 Category: Pediatrics Authors: Jenny Fernandez Tags: Diseases & Conditions Our Patients’ Stories Christopher Baird complex congenital heart defect Heart Center hypoplastic left heart syndrome Wayne Tworetzky Source Type: news

Government notifies 15 medical devices as drugs for price regulation
Apart from catheters, stents and orthopaedic implants, the list also includes heart valves, intra-ocular lenses, syringes and needles. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 6, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves New'Resilient' Inspiris Heart Valve FDA Approves New'Resilient' Inspiris Heart Valve
The valve is currently surgically implanted, but designed with an eye for future valve-in-valve procedures.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 5, 2017 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

FDA Approves New & quot;Resilient & quot; Inspiris Heart Valve FDA Approves New & quot;Resilient & quot; Inspiris Heart Valve
The valve is currently surgically implanted, but designed with an eye for future valve-in-valve procedures.FDA Approvals (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - July 5, 2017 Category: Cardiology Tags: Cardiology News Alert Source Type: news

Edwards Lifesciences wins FDA approval for Inspiris Resilia valve
Edwards Lifesciences (NYSE:EW) said today that it won pre-market approval from the FDA for its Inspiris Resilia surgical aortic valve replacement, claiming it as “the first in a new class of resilient heart valves.” Irvine, Calif.-based Edwards said the valve uses its Resilia tissue technology, which is designed to inhibit calcification and improve hemodynamic performance and dry storage. The company also touted Inspiris Resilia’s VFit expandable frame, which features size markers for later valve-in-valve procedures, and the underlying Carpentier-Edwards Perimount valve design. Edwards said it&r...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Medical News Today: 3-D-printed models could transform heart valve replacements
A study shows how 3-D-printed heart valve models can predict how well a prosthetic heart valve will fit a patient, which could lower their risk of leakage. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - July 4, 2017 Category: Consumer Health News Tags: Heart Disease Source Type: news

Grandmother died after surgeon ‘re-inserted heart valve'
Sheila Hynes (pictured) died two days after an operation at Freeman Hospital in Newcastle. During the operation a heart ventricle was placed on its mounting the wrong way round. (Source: the Mail online | Health)
Source: the Mail online | Health - June 19, 2017 Category: Consumer Health News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 16, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. When designing medical devices, consider the hands Our hands are the emotional and physical link to our environment. They are also the link to our brain. “What I try to tell people is how complicated the hand is,” B...
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Neovasc loses German patent case against Edwards Lifesciences unit CardiAQ Valve
Neovasc (NSDQ:NVCN) shares are down more than 6% today after the replacement heart valve maker said it lost a patent case in Germany against arch-rival and Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve The District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe; no money was involved in the decision, Vancouver-based Neovasc said, noting its intention to appeal. A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misa...
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Patent Infringement Replacement Heart Valves Wall Street Beat CardiAQ Valve Technologies Edwards Lifesciences Neovasc Inc. Source Type: news

How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve
Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D. Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) was no longer working properly and they were too sick for surgery. Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of these patients.  But the U...
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog FDA Voice Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 15, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Johnson & Johnson Innovation backs 3D printing, coatings and contact lenses Johnson & Johnson Innovation, the incubation arm of healthcare giant Johnson & Johnson, said today that it’s investing in a variety o...
Source: Mass Device - June 15, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

China ’ s Venus Medtech snaps up TAVR device developer InterValve
Chinese heart valve maker Venus Medtech said today it acquired U.S.-based transcatheter aortic valve replacement device developer InterValve for an undisclosed amount. Intervalve produces the V8 and TAV8 aortic valvuloplasty balloon catheters designed for performing percutaneous balloon angioplasty procedures and for pre and post-dilation during TAVR procedures. Venus said that the shape of the balloon helps protect the valve annulus structure and minimize expansion of the valve. Both the V8 and TAV8 balloons have FDA approval and CE Mark approval in the European Union, Venus Medtech said. “The balloon of Interv...
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters Mergers & Acquisitions InterValve Inc. Venus Medtech Source Type: news

How Creative FDA Regulation Led to First-in-the-World Approval of a Cutting-Edge Heart Valve - FDA Voice Blog - https://go.usa.gov/xNpCF  
How Creative FDA Regulation Led to First-in-the-World Approval of a Cutting-Edge Heart Valve - FDA Voice Blog - https://go.usa.gov/xNpCF  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 14, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and pre...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news

Artificial Heart Valve Approved for Valve-in-Valve Treatment (FREE)
By Kristin J. Kelley Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM Sapien 3 transcatheter heart valves may now be used as " a valve-in-valve " … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - June 7, 2017 Category: Primary Care Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 6, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Report: Valeant shopping sale of surgical eye biz Valeant Pharmaceuticals is looking to sell its Bausch & Lomb division’s surgical product assets to Carl Zeiss Meditec, according to a Bloomberg report. The surgical ey...
Source: Mass Device - June 6, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

#FDA expands use of Sapien 3 artificial heart valve 4 high-risk patients https://go.usa.gov/xNEGz   #heartdisease #medicaldevice
#FDA expands use of Sapien 3 artificial heart valve 4 high-risk patients https://go.usa.gov/xNEGz  #heartdisease #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 6, 2017 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA approves valve-in-valve procedures for Edwards Lifesciences Sapien 3 TAVR
The FDA yesterday expanded the indication for the Sapien 3 replacement heart valve made by Edwards Lifesciences (NYSE:EW) to include valve-in-valve procedures for aortic and mitral valve patients who are too sick for surgery. The federal safety watchdog said the expansion is the 1st approval for a transcatheter valve replacement for valve-in-valve procedures when the original surgically implanted valves fail. The procedure involves inserting the Sapien 3 device inside the failed or failing valve. “For the 1st time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatme...
Source: Mass Device - June 6, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Wall Street Beat Edwards Lifesciences Source Type: news

FDA approves new use for Edwards' Sapien 3 heart valve
(Reuters) - The U.S. Food and Drug Administration on Monday approved Edwards Lifesciences Corp's Sapien 3 artificial heart valve for high-risk patients whose previously implanted heart valves are failing, a procedure designed to avoid repeat open heart surgery. (Source: Reuters: Health)
Source: Reuters: Health - June 5, 2017 Category: Consumer Health News Tags: healthNews Source Type: news