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Good Outcomes After TAVR for Failed Surgical Bioprostheses Good Outcomes After TAVR for Failed Surgical Bioprostheses
Patients who undergo transcatheter aortic valve replacement (TAVR) for failed surgical bioprostheses have good 1-year outcomes with low mortality rates, according to results from the CoreValve US Expanded Use Study.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - May 25, 2017 Category: Surgery Tags: Cardiology News Source Type: news

Democratic congressman has heart valve replacement procedure
The top Democrat on the House Oversight and Government Reform Committee has undergone a heart procedure and will remain hospitalized for a few days (Source: ABC News: Health)
Source: ABC News: Health - May 25, 2017 Category: Consumer Health News Tags: Health Source Type: news

Protective Effect of Sevoflurane vs Propofol in HVR Surgery Protective Effect of Sevoflurane vs Propofol in HVR Surgery
This study compared the cardioprotective effect of anesthesia with intravenous propofol versus inhaled sevoflurane in patients undergoing mitral, aortic or tricuspid valve replacement surgery.BMC Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 24, 2017 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Surgeon rewarded by aiding infants
Repairing holes in the heart and correcting mitral valve stenosis in Atlanta ’s most fragile patients are all part of a typical workday for Dr. Subhadra Shashidharan. And the rewards come in the form of a smile. For this pediatric cardiac surgeon, there is nothing more heartwarming than the happy, smiling face of a baby that is recovering from heart surgery. “They are j ust happy. They don’t complain and they bounce back from surgery,” she said. “The technical aspects are challenging and… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - May 23, 2017 Category: Biotechnology Source Type: news

Surgeon rewarded by aiding infants
Repairing holes in the heart and correcting mitral valve stenosis in Atlanta ’s most fragile patients are all part of a typical workday for Dr. Subhadra Shashidharan. And the rewards come in the form of a smile. For this pediatric cardiac surgeon, there is nothing more heartwarming than the happy, smiling face of a baby that is recovering from heart surgery. “They are j ust happy. They don’t complain and they bounce back from surgery,” she said. “The technical aspects are challenging and… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 23, 2017 Category: American Health Source Type: news

Robot hearts: medicine ’s new frontier
From bovine valves to electrical motors and 3-D printed hearts, cardiologists are forging ahead with technologies once dismissed as “crazy ideas”On a cold, bright January morning I walked south across Westminster Bridge to St Thomas ’ Hospital, an institution with a proud tradition of innovation: I was there to observe a procedure generally regarded as the greatest advance in cardiac surgery since the turn of the millennium – and one that can be performed without a surgeon.The patient was a man in his 80s with aortic stenosis, a narrowed valve which was restricting outflow from the left ventricle in...
Source: Guardian Unlimited Science - May 23, 2017 Category: Science Authors: Thomas Morris Tags: Science Health Society Heart attack Technology Engineering Source Type: news

Harvard researchers reveal ‘ JetValves ’ , nanofiber heart valves with potential to regenerate, grow
In this study, we used a combination of synthetic polymers and ECM proteins to fabricate biocompatible JetValves that are hemodynamically competent upon implantation and support cell migration and re-population in vitro. Importantly, we can make human-sized JetValves in minutes – much faster than possible for other regenerative prostheses,” JetValve team lead Kevin Parker of Harvard’s Wyss Institute said in a prepared release. Today, both groups said they formed a cross-institutional team looking to generate a functional heart valve replacement with regenerative, reparative and growth potentials. The...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Replacement Heart Valves Research & Development Harvard Wyss Institute Source Type: news

Engineering heart valves for the many
Medical researchers announced today a cross-institutional team effort to generate a functional heart valve replacement with the capacity for repair, regeneration, and growth. The team is also working towards a GMP-grade version of their customizable, scalable, and cost-effective manufacturing process that would enable deployment to a large patient population. In addition, the new heart valve would be compatible with minimally invasive procedures to serve both pediatric and adult patients. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 18, 2017 Category: Science Source Type: news

Engineering heart valves for the many
(Wyss Institute for Biologically Inspired Engineering at Harvard) The Wyss Institute for Biologically Inspired Engineering and the University of Zurich announced today a cross-institutional team effort to generate a functional heart valve replacement with the capacity for repair, regeneration, and growth. The team is also working towards a GMP-grade version of their customizable, scalable, and cost-effective manufacturing process that would enable deployment to a large patient population. In addition, the new heart valve would be compatible with minimally invasive procedures to serve both pediatric and adult patients. (Sou...
Source: EurekAlert! - Biology - May 18, 2017 Category: Biology Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 17, 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. 10 innovative diagnostic tests to combat diseases Medtech is seeing new exciting developments in the field of medical diagnostics, with recent innovations allowing for faster disease diagnosis than ever before. We cover 10 diag...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Xeltis touts preclinical bioresorbable heart valve data
Xeltis today released early data on its bioresorbable heart valves built on endogenous tissue restoration technology, touting potential benefits of the regenerative approach to heart valve replacement. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure with naturally regrown tissue, and the company is currently testing the system in pulmonary and aortic valves. “Our objective is to change the paradigm for heart valve treatment. If ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Replacement Heart Valves Research & Development Xeltis Source Type: news

Edwards' Novel Self-Expanding Transcatheter Heart Valve Demonstrates Excellent Early Patient Outcomes
PARIS, May 17, 2017 -- (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 late-breaking data at... Devices, Interventional, Cardiology Edwards Lifesciences, transcatheter aortic valve replacement, CENTERA valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 17, 2017 Category: Pharmaceuticals Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 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. Corindus touts high success rate in CorPath 200 PCI registry study Corindus Vascular Robotics today released post-market findings from the Precision registry study of its CorPath 200 system used during percutaneous coronary int...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic looks to settle TAVR patent spat with doc inventor
Medtronic (NYSE:MDT) is looking to settle a patent infringement dispute over transcatheter aortic valve replacements with a doctor who sued the company and cross-town rival St. Jude Medical (NYSE:STJ), which last week lost its bid to have the case dismissed. Dr. Robert Snyder, founder of Snyders Heart Valve, filed suits last year in the U.S. District Court for Eastern Texas claiming that both companies used technologies covered by his patents for an artificial heart valve and delivery system called the Funnel valve, according to court documents. The lawsuits, which were later consolidated, allege that St. Jude&rs...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Patent Infringement Replacement Heart Valves Medtronic Snyder Heart Valve stjudemedical Source Type: news

EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients. The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic Source Type: news

Boston Scientific closes $435m Symetis buyout
Boston Scientific (NYSE:BSX) said today that it closed its $435 million buyout of Symetis and its line of minimally invasive replacement heart valves. The buyout, announced in March, halted the 2nd run at an initial public offering by Symetis, which launched the IPO March 20 in a bid to raise up to $66 million (€61.5 million) on the Euronext exchange in Paris. The Ecublens, Switzerland-based company, which acquired Middle Peak Medical and its transcatheter mitral valve implant just last month, spiked its 1st $96 million IPO attempt in September 2015. Sym...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Symetis Source Type: news

Analysis looks at role type of valve plays in patient outcomes post-TAVR
(Society for Cardiovascular Angiography and Interventions) Results from 'Impact of valve design and bivalirudin vs. unfractionated heparin for anticoagulation in transcatheter aortic valve replacement: Results from the BRAVO-3 trial' were presented today as a late-breaking clinical trial at the Society for CardiovascularAngiography and Interventions (SCAI) 2017 Scientific Sessions in New Orleans. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 12, 2017 Category: International Medicine & Public Health Source Type: news

Analysis shows increased risk of early stroke with new-onset atrial fibrillation post-TAVR
(Society for Cardiovascular Angiography and Interventions) Results from 'Effect of bivalirudin versus unfractionated heparin in patients with baseline or new-onset atrial fibrillation in transcatheter aortic valve replacement: From the BRAVO-3 randomized trial' were presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions in New Orleans. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - May 11, 2017 Category: International Medicine & Public Health Source Type: news

CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery. Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week. The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids. Th...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. Source Type: news

UK ’ s MHRA issues alert over SVD issues in select Mitroflow LX valves
The UK’s Medicines and Healthcare products Regulatory Agency today published a notice warning of an increased risk of early structural valve deterioration in select LivaNova (NSDQ:LIVN) Mitroflow LX pericardial aortic heart valves. The alert applies only to Mitroflow LX model valves marketed in the UK between 2005 and 2014, and indicates that patients implanted with the smaller sizes of the valve are prone to early SVD. The MHRA said it estates that less than 80 of the small sized valves were sold in the UK over the past 5 years, and that the number of affected patients is expected to be “comparatively low...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance Replacement Heart Valves LivaNova Source Type: news

LivaNova sees shares rise on Q1 EPS beat
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker beat EPS expectations on Wall Street with its 1st quarter results. The London-based company posted profits of $11.3 million, or 23¢ per share, on sales of $285.1 million for the 3 months ended March 31, seeing a 128% swing from the red on the bottom-line while sales shrunk 0.7% compared with the same period last year. Adjusted to exclude 1-time items, earnings per share were 71¢, ahead of the 68¢ consensus on The Street, where analysts were looking for sales of $287.7 million. “We started out the year with solid results, driv...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup LivaNova Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 3, 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. 10 companies with interesting technology at BIOMEDevice Boston BIOMEDevice Boston is an opportunity for over 4,000 engineers and executives and 400 suppliers in New England’s design and manufacturing industry to connect. ...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

LivaNova buys out Caisson Interventional for $72m
LivaNova (NSDQ:LIVN) yesterday said it put up $72 million to acquire the remaining stake in Caisson Interventional, which is developing a implantable device to replace the heart’s mitral valve. Maple Grove, Minn.-based Caisson’s transcatheter mitral valve replacement is designed to be delivered across the heaert’s septum via the femoral vein and can be repositioned or withdrawn before final deployment. The 1st patients in the 20-patient Prelude investigational device exemption study were implanted with the device last year. LivaNova said it put up $18 million when the deal closed and i...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat caissoninterventional LivaNova Source Type: news

Busiest Docs Get Best Results With Heart Valve Surgery
Title: Busiest Docs Get Best Results With Heart Valve SurgeryCategory: Health NewsCreated: 5/2/2017 12:00:00 AMLast Editorial Review: 5/3/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - May 3, 2017 Category: Cardiology Source Type: news

New Zealand OKs CE Mark trial for Medeon Biodesign ’ s XPro large-bore vascular closure device
Medeon Biodesign said today it won approval from the New Zealand Ministry of Health’s Health and Disability Ethics Committees to initiate a clinical trial of its XPro suture-mediated vascular closure device as it seeks CE Mark approval. The study will examine the safety and effectiveness of the XPro System in facilitating hemostasis in patients undergoing percutaneous endovascular procedures including transcatheter aortic valve implantation, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon valvuloplasty procedures. A total of 60 patients will be enrolled in the trial i...
Source: Mass Device - May 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Regulatory/Compliance Vascular Medeon Biodesign Source Type: news

Busiest Docs Get Best Results with Heart Valve Surgery
Patients more likely to receive repair than replacement from the most experienced surgeons, study finds Source: HealthDay Related MedlinePlus Pages: Heart Surgery, Heart Valve Diseases (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 2, 2017 Category: Consumer Health News Source Type: news

Busiest Docs Get Best Results With Heart Valve Surgery
TUESDAY, May 2, 2017 -- Patients who have heart valve surgery get better results and are more likely to survive if their surgeon does a lot of the operations, a new study. Researchers from Mount Sinai Health System in New York City studied New York... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 2, 2017 Category: Journals (General) Source Type: news

Venus Medtech wins Chinese FDA approval for Venus A-valve TAVR
Chinese heart valve maker Venus Medtech said today it won China FDA approval for its Venus A-valve device, touting it as the 1st transcatheter aortic valve implantation device to win CFDA approval. The Venus A-valve device offers a less invasive treatment solution for inoperable and high-risk patients, providing a solution to patients in the region that previously was unavailable, the Hangzhou-based company said. “We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at h...
Source: Mass Device - April 28, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Venus Medtech Source Type: news

The Patients We Do Not See
This article was originally published on The Conversation. Read the original article. -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website. (Source: Healthy Living - The Huffington Post)
Source: Healthy Living - The Huffington Post - April 28, 2017 Category: Consumer Health News Source Type: news

MassDevice.com +5 | The top 5 medtech stories for April 20, 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. NuVasive launches Reline Trauma posterior fixation portfolio NuVasive Inc. said yesterday it launched its Reline Trauma spinal posterior fixation portfolio designed to aid in the preservation and restoration of patient alignmen...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

FDA labels Medtronic StrataMR recall as Class I
The FDA today released updated information on Medtronic‘s (NYSE:MDT) recall of StrataMR adjustable valves and shunts over issues with fluid buildup, labeling it as Class I. The StrataMR adjustable valves and shunts are intended for the management of hydrocephalus by providing cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The recall relates to issues with flow resistance that could lead to under-drainage of cerebrospinal fluid, arising when the valve mechanism is adjusted to a position which causes higher-than-intended flow r...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Recalls Medtronic Source Type: news

Princeton Baptist Medical Center offers new aortic procedure
Princeton Baptist Medical Center has performed the first surgery in the state using a new treatment for severe aortic stenosis. It's the first facility in the Southeast to offer the technology - a new transcatheter aortic valve replacement procedure with a self-expanding implant and advanced sealing. The newly FDA-approved CoreValve Evolut PRO TAVR is for symptomatic patients who are at high or extreme risk for open heart surgery. “One of our strongest areas of expertise is treating patients… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 18, 2017 Category: American Health Authors: Stephanie Rebman Source Type: news

Heart surgeons actively involved with TAVR patients every step of the way
Cardiothoracic surgeons are fully invested in the patient-centered, team-based model of care, guiding patients through the entire transcatheter aortic valve replacement (TAVR) experience, from the decision to undergo TAVR to discharge from the hospital and return to normal activities, according to a new survey. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - April 11, 2017 Category: Science Source Type: news

Conscious sedation is a safe alternative to general anesthesia for heart valve procedure
(University of California - Los Angeles Health Sciences) UCLA scientists have found that conscious sedation -- a type of anesthesia in which patients remain awake but are sleepy and pain-free -- is a safe and viable option to general anesthesia for people undergoing a minimally invasive heart procedure called transcatheter aortic valve replacement. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 11, 2017 Category: Global & Universal Source Type: news

Conscious sedation is a safe alternative to general anesthesia for heart valve procedure
FINDINGSUCLA scientists have found that conscious sedation — a type of anesthesia in which patients remain awake but are sleepy and pain-free — is a safe and viable option to general anesthesia for people undergoing a minimally invasive heart procedure called transcatheter aortic valve replacement.In the study, patients who underwent conscious sedation had a similar rate of adverse events to those who underwent anesthesia, but those who were given conscious sedation had shorter stays in the intensive care unit (30 versus 96 hours for those with general anesthesia) and shorter hospital stays (4.9 days versus 10....
Source: UCLA Newsroom: Health Sciences - April 11, 2017 Category: Universities & Medical Training Source Type: news

Your NEJM Group Today: TAVR Clinical Pearls / Prophylactic Double Mastectomy Decisions / Milan Director Opportunity (FREE)
By the Editors Here's what we chose for you from NEJM Group today:NEJM Resident 360: Clinical Pearls: Is transcatheter aortic-valve replacement widely used for patients … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - April 11, 2017 Category: Primary Care Source Type: news

HLT launches feasibility trial for Meridian TAVR
HLT said today that it launched a feasibility trial of its Meridian TAVR in a high-risk patient cohort. Maple Grove, Minn.-based HLT said the 20-patient Radiant study is a prospective, non-randomized, single-arm trial with an endpoint of all-cause mortality at 30 days. Follow-up is slated for 1, 5 and 12 months after implantation, and then annually to 5 years. The 1st implantations in the trial were performed at the Quebec Heart & Lung Institute, the company said. HLT, which is owned by Milan-based Bracco Group, is a sister company of advanced contrast delivery and cardiology imaging syste...
Source: Mass Device - April 4, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat ACIST Medical Systems Bracco Diagnostics HLT Source Type: news

Analyst: Boston Scientific could be eyeing a Neovasc buyout
Boston Scientific (NYSE:BSX) is a potential acquirer for mitral valve maker Neovasc (NSDQ:NVCN), according to JMP Securities analyst John Gillings, after agreeing to a $435 million deal for aortic valve maker Symetis that doesn’t include its Middle Peak Medical mitral valve assets. Although the all-cash Symetis deal adds the market-ready Acurate transcatheter aortic valve implant to Boston Scientific’s structural heart portfolio, interventional cardiology president Kevin Ballinger told analysts during a conference call that the Middle Peak assets don’t fit in with its other programs. &...
Source: Mass Device - March 31, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Mvalve Neovasc Inc. Symetis Source Type: news

Boston Scientific to buy Swiss company for $435M
Boston Scientific Corp. has reached a deal to buy Swiss medical-device maker Symetis for $435 million in cash. Symetis makes devices that let physicians replace heart valves without cracking open a patient's chest. The market for such transcatheter-valve technology has heated up in recent years, though only two companies have approval to sell the devices in the U.S. Symetis, which has about 300 employees, is conducting a clinical trial it needs to seek European regulatory approval. Boston Scientific… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 30, 2017 Category: Pharmaceuticals Authors: Katharine Grayson Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 30, 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. ADM Cleveland: Here are some top medtech manufacturing highlights The inaugural Advanced Design and Manufacturing is showcasing some of the medical device industry’s top design and manufacturing technology this week at th...
Source: Mass Device - March 30, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Boston Scientific puts up $435m for Symetis just ahead of IPO
Boston Scientific (NYSE:BSX) is putting up $435 million in cash for Symetis and its line of minimally invasive replacement heart valves, the companies said today. The buyout halts the 2nd run at an initial public offering by Symetis, which launched the IPO March 20 in a bid to raise up to $66 million (€61.5 million) on the Euronext exchange in Paris. The Ecublens, Switzerland-based company, which acquired Middle Peak Medical and its transcatheter mitral valve implant just last month, spiked its 1st, $96 million IPO attempt in September 2015. Symetis employs a...
Source: Mass Device - March 30, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Symetis Source Type: news

Runner, 80, completes L.A. Marathon three months after major heart surgery
Claude Bruni has 98 marathon races under his belt, including every Los Angeles Marathon since 1986. Nothing can keep Bruni, who ’s 80, from running.Not even major surgery, as it turns out.Last December, the retired owner of auto repair shop from Century City needed open heart surgery. But the 2017 L.A. Marathon was right around  the corner, and there was no way Bruni would miss it. He told his doctor that his goal was to participate in the race that was only three months away — on March 19.“I told him that I couldn’t see how anyone could recover from major cardiac surgery and run a maratho...
Source: UCLA Newsroom: Health Sciences - March 25, 2017 Category: Universities & Medical Training Source Type: news

Embolic'Protection' at SAVR: Data Disappoint but Optimism Reigns Embolic'Protection' at SAVR: Data Disappoint but Optimism Reigns
Surely it's good"to stop all that junk from going up into the head," they agreed. But the embolic-protection devices used at aortic-valve surgery in a trial didn't prevent strokes clinically or by MRI. (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - March 25, 2017 Category: Cardiology Tags: Cardiology News Source Type: news

New Guidelines Support Expanded Use of TAVR New Guidelines Support Expanded Use of TAVR
Updated guidelines from the American Heart Association/American College of Cardiology (AHA/ACC) support expanded use of transcatheter aortic valve replacement (TAVR), among other recommendations.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - March 24, 2017 Category: Surgery Tags: News Source Type: news

BioStable Science & Eng wins FDA nod for Haart 300 aortic annuloplasty device
Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device. The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer. “We are very grateful for the cooperation between the BioStable management team and FDA that allowed the company to obtain this market clearance earlier than anticipated, and we look forward to the Haart 300 Aortic Annuloplasty Devi...
Source: Mass Device - March 23, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves BioStable Science & Engineering Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 22, 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. Japan clears Novocure’s 2nd gen Optune device Novocure said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its 2nd-gen Optune device. The Optune is a mobile device that delivers low-int...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

Medtronic Receives FDA Approval for CoreValve ™ Evolut™ Pro Transcatheter Valve with Advanced Sealing
Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve ™ Evolut™ PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Sessio n, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - March 22, 2017 Category: Cardiology Source Type: news

Medtronic wins FDA nod for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter arortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen 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. “Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited ...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

ACC 2017 Roundup: Abbott touts reduced HF rehospitalizations in MitraClip study
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19.   Abbott touts reduced HF rehospitalizations in MitraClip study Abbott (NYSE:ABT) released 1-year outcomes from the largest study to-date of real-world experiences for its MitraClip system in transcatheter mitral valve repair procedures in the US at the ACC 2017 annual meeting. The Abbott Park, Ill.-based company’s MitraClip was designed to treat patients with degenerative mitral regurgitation who were not el...
Source: Mass Device - March 20, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Abiomed ACC 2017 Medtronic Royal Philips Source Type: news

CT scans reveal reduced leaflet motion after aortic valve replacement
About 12 percent of patients undergoing aortic valve replacement developed non-symptomatic blood clots around the valve leaflets (known as subclinical leaflet thrombosis) that reduced the motion of the valves, according to an observational study. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 20, 2017 Category: Science Source Type: news