Edwards Lifesciences pays $180m to bury the hatchet with Boston Scientific
Boston Scientific (NYSE:BSX) and Edwards Lifesciences (NYSE:EW) said today that they’re burying the hatchet, settling their worldwide patent war over cardiac valve and implant technology, with Edwards paying $180 million to end the dispute. “All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted,” the companies...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Legal News Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences Source Type: news

3D-printed implants anchor spinal cord regeneration
Researchers from California have created 3D-printed implants modeled from MRI...Read more on AuntMinnie.comRelated Reading: 3D printing offers alternative to CT-guided lung surgery 3D printing technique improves heart valve sizing 3D head models reduce workload for brain radiotherapy 3D-printed device aids knee replacement surgery 3D-printed aortas could work well for TAVR (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 15, 2019 Category: Radiology Source Type: news

Hancock Jaffe sets endpoints for FIH VenoValve study
Hancock Jaffe Laboratories (NSDQ:HJLI) today announced the endpoints for its planned first-in-human study 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. Endpoints for the study include improvements in reflux time measured by duplex scans and rVCSS, VAS and VEINES scores, which are used as clinical measurements for venous disease. Hancock Jaffe said that patients in the trial will be monitored at reg...
Source: Mass Device - January 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves hancockjaffelabs Source Type: news

Thubrikar Aortic Valve launches Brazilian TAVR trial
Privately held medical device developer Thubrikar Aortic Valve said yesterday that it launched a Brazilian trial of its Optimum transcatheter aortic valve using the company’s implantation system. The Norristown, Penn.-based company touted that the first human implant has been performed in the trial, which is being sponsored by the company’s Brazilian licensee, Labcor Laboratórios, who also manufactured the valve. “We are very pleased to initiate this clinical trial of the licensed technology from Thubrikar and anticipate completion of the trial in 2019,” Labcor co-founder Dr. Ivan Casagrande ...
Source: Mass Device - January 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves thubrikaraorticvalve Source Type: news

JC Medical touts first U.S. treatment with transfemoral TAVR system
JC Medical said today that the company’s first U.S.-based patient was treated with its transfemoral transcatheter aortic valve implant system, J-Valve TF. The FDA approved the use of J-Valve for people with aortic regurgitation through its “compassionate use” pathway. JC Medical also noted that it’s gearing up for a clinical trial of the investigational device in the U.S. this year. The first U.S. patient to use JC Medical’s J-Valve TF system was treated at The Christ Hospital in Cincinnati, Ohio by Dr. Dean Kereiakes, who serves as the medical co-director of the Lindner Research Center. ...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Featured Replacement Heart Valves JC Medical Source Type: news

3D printing offers alternative to CT-guided lung surgery
An international team of researchers created 3D-printed navigational templates...Read more on AuntMinnie.comRelated Reading: 3D printing technique improves heart valve sizing AR, 3D printing make headway in patient education 3D printing gives pediatric heart surgery a boost 3D-printed lungs improve patient understanding of surgery 3D head models reduce workload for brain radiotherapy (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 3, 2019 Category: Radiology Source Type: news

Edwards' SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Irvine, Calif., Dec. 28, 2018 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery....This story is related to the following:Surgical Implants (Source: Industrial Newsroom - Health, Medical and Dental Supplies)
Source: Industrial Newsroom - Health, Medical and Dental Supplies - January 2, 2019 Category: Medical Devices Source Type: news

World surgical first sees 66-year-old blocked heart valve cleared with a live wire up his leg  
Leaky heart valves can leave patients struggling for breath and lead to heart failure. Repair usually involves open heart surgery but Michael Hammond, of Hove, had an alternative. (Source: the Mail online | Health)
Source: the Mail online | Health - January 2, 2019 Category: Consumer Health News Source Type: news

Edwards Heats up TAVR Market with New Approval
Edward Lifesciences’s long-awaited Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System has received a nod from FDA. The Irvine, CA-based company had received CE mark for the valve in November. The Sapien 3 Ultra valve features a heightened outer skirt designed to eliminate paravalvular leak. The new delivery system introduces an "on balloon" design, removing the need for valve alignment during the procedure. "The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our be...
Source: MDDI - December 28, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

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 alignmen...
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

TAVR Helpful Irrespective of LV Dysfunction and Contractile Reserve TAVR Helpful Irrespective of LV Dysfunction and Contractile Reserve
Transcatheter aortic valve replacement (TAVR) is beneficial even in patients with low-flow, low-gradient aortic stenosis and severe left ventricular dysfunction, according to North American and European researchers.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 27, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Latest Boston Sci Deal Shakes up Mitral Repair Market
Boston Scientific is slipping in one more deal (maybe?) before 2018 ends, and it could have significant implications. This time out, the Marlborough, MA-based company will gain a stronger foothold in the transcatheter mitral repair and replacement market by exercising its option to acquire the remaining shares of Millipede Inc. The deal will have Boston Scientific doling out $325 million with a $125 million payment becoming available upon achievement of a commercial milestone. The Millipede acquisition is set to close prior to the end of 1Q19. Boston Scientific’s latest acquisition target is developing th...
Source: MDDI - December 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Boston Scientific acquires Millipede for $325m
Boston Scientific (NYSE:BSX) said today that it acquired Iris transcatheter annuloplasty ring developer Millipede in a deal worth approximately $325 million with the opportunity for an additional $125 million based on a commercial milestone. Santa Rosa, Calif.-based Millipede makes the Iris transcatheter annuloplasty ring for treating mitral valve regurgitation. Marlborough, Mass.-based Boston Scientific initially invested $90 million into Millipede in January, with an option to acquire the remaining shares in the company for $325 million and an additional $125 million milestone payment. Boston Scientific said th...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured Mergers & Acquisitions Wall Street Beat Boston Scientific millipede 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...
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

Innovative Cardiovascular Solutions closes $8m Series C
Innovative Cardiovascular Solutions said today that it closed an $8 million Series C round of financing to support clinical trials of its Emblok embolic protection system as well as manufacturing and operational activities. The Kalamazoo, Mich.-based company’s Emblok system is an embolic protection device designed for full circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from embolic debris. The system is designed for use in transcatheter aortic valve replacement and structural heart procedures and includes an integrated 4 French radiopaque pigtail catheter to prov...
Source: Mass Device - December 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Wall Street Beat Innovative Cardiovascular Solutions 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

How Boston Scientific Reinvented Itself in 2018
When MD+DI editors were voting to see which medtech firm would be named 2018 Company of the Year, Boston Scientific immediately stood out. The Marlborough, MA-based company has had an incredible year. From deals, to a more open line of communication, to getting a troubled product back on track, the firm has been making extraordinary strides. The heart of the matter is that the medtech landscape is far different than it was 10 years ago. Boston Scientific’s rivals have grown exponentially due to mega-mergers. The nearly 40-year-old company now faces off against a combined might of Medtronic and Covidien, i...
Source: MDDI - December 17, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business 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 i...
Source: Mass Device - December 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves hancockjaffelabs Source Type: news

Valve Surgery and Opioids; Hospital Alarm Fatigue: It's PodMed Double T! (with audio)
(MedPage Today) -- This week's topics also include prostatectomy versus watchful waiting, and flu vaccines and heart failure (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - December 15, 2018 Category: Psychiatry 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. D...
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

Edwards Lifesciences, Bay Labs ink cardio-focused collab AI-dev deal
Edwards Lifesciences’ (NYSE:EW) and  cardiovascular artificial intelligence medtech firm Bay Labs, have inked a multi-faceted collaborative cardiovascular-focused development deal, Bay Labs said today. San Francisco-based Bay Labs said that the partnership involves multiple initiatives including the development of new AI-powered algorithms in Bay Labs’ EchoMD software suite and the integration of EchoMD algorithms into Edwards’ CardioCare quality care navigation platform, as well as support for ongoing clinical studies. “Our vision is to improve patient care throughout the continuum from d...
Source: Mass Device - December 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Research & Development baylabs Edwards Lifesciences 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

Meril Life Sciences wins approval for TAVR in India
Meril Life Sciences’ MyVal TAVR device Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company’s website. India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a r...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Central Drugs  Standard Control Organisation Meril Life Science Source Type: news

FDA panel votes in support of Impulse Dynamic ’ s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device s...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Impulse Dynamics Source Type: news

Edwards prioritizes TAVR, TMTT tech in investor day presentation
Edwards Lifesciences (NYSE:EW) today released its strategies for longer-term growth, updated on its technology pipeline and released preliminary financial guidance for the coming fiscal year in its investor day presentation. Edwards lead with news about its transcatheter aortic valve replacement technologies, saying it expects that TAVR opportunity will reach approximately $7 billion by 2024, and that it estimates its TAVR sales next year will be between $2.4 billion and $2.7 billion. The Irvine, Calif.-based company said that it plans to continue investing in TAVR research & development and clinical trials and th...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat Edwards Lifesciences Source Type: news

Is 2019 Going to Be a Standout Year for TAVR?
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk. The Irvine, CA-based company said the prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand. Approval for addition...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Pivotal trial kicks off for Edwards Lifesciences ’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said. The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said. “As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news

FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand. “We are extremely pleased with the initial clinica...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves JenaValve Source Type: news

Medtronic studies use of both heat and cold for cardiac ablation
Medtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment. The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic. During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used bot...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Cardiovascular Clinical Trials Featured News Well Research & Development Surgical Medtronic Source Type: news

Sutureless aortic valve replacement cost  effective
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - December 1, 2018 Category: Drugs & Pharmacology Source Type: news

Survival and Stroke Similar for TAVR and SAVR at 5 Years Survival and Stroke Similar for TAVR and SAVR at 5 Years
The early mortality benefit seen with transcatheter aortic valve replacement over surgical repair in patients with severe aortic stenosis at high surgical risk is no longer significant at 5 years.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 26, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Lipoprotein Levels May Inform Timing of Aortic Valve Replacement
(MedPage Today) -- Linear relationship seen with worsening aortic valve stenosis (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - November 23, 2018 Category: Cardiology Source Type: news

Cardiac surgery and addictions counselling linked to significantly reduced mortality in injection drug users with heart valve infection, study finds
(Lawson Health Research Institute) In a new study, researchers at Lawson Health Research Institute and Western University showed that both surgery and in-hospital addictions counselling are linked to significantly reduced mortality in injection drug users with first-episode endocarditis. Surgery was associated with a 56 per cent reduction in mortality, while in-hospital addictions counselling was associated with a 72 per cent reduction. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - November 21, 2018 Category: Infectious Diseases Source Type: news

Patient Outcomes Tied to Valve Replacement Volume
MONDAY, Nov. 19, 2018 -- Hospitals with high caseloads of both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) have the best outcomes, according to a study published online Oct. 31 in JAMA... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2018 Category: Pharmaceuticals Source Type: news

Edwards & #039; Sapien 3 Ultra Valve Wins CE Mark
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston Scientific. The CE mark allows Edwards to market the device in Europe for patients with severe, symptomatic aortic stenosis. "Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy," the company said in a press release. The Germany case involves a European patent  Boston Scientific acquired in 2017 when it bo...
Source: MDDI - November 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Euro...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Neovasc dives on Q3 bottom-line miss
Neovasc (NSDQ:NVCN) shares took a hit this morning after the cardiac device maker missed expectations for its third-quarter losses. Vancouver-based Neovasc, which makes the Reducer refractory angina device and the Tiara transcatheter mitral valve replacement, said its losses grew 122.3% to -$12.9 million, or -70¢ per share, as sales fell -65.0% to $480,540 for the three months ended Sept. 30. Although the top-line number was in-line with the consensus forecast, analysts on Wall Street were looking for losses of -21¢ per shares. The results pushed NVCN shares, which closed down -3.8% at $1.79 apiece yesterday...
Source: Mass Device - November 15, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured MassDevice Earnings Roundup Replacement Heart Valves Wall Street Beat neovasc Source Type: news

Surgical robot BOTCHES surgery, kills man on operating table while doctors sipped lattes
(Natural News) In the name of scientific “progress,” Newcastle’s Freeman Hospital in the United Kingdom recently tried to pioneer the use of a surgical robot that it tasked with repairing a patient’s damaged heart valve, only to have the machine go completely bonkers and ultimately kill the man on the operating table. According to reports,... (Source: NaturalNews.com)
Source: NaturalNews.com - November 14, 2018 Category: Consumer Health News Source Type: news

Channel 5 viewers applaud surgeons who conducted open heart surgery live on air
GRAPHIC CONTENT: The first episode of Operation Live aired last night and London heart surgeon Kulvinder Lall performed an aortic valve replacement on a 69-year-old man. (Source: the Mail online | Health)
Source: the Mail online | Health - November 14, 2018 Category: Consumer Health News Source Type: news

NeoChord raises $25m in Series D
NeoChord said yesterday it closed a $25 million Series D equity financing round to help support its mitral valve repair system intended to treat mitral valve regurgitation. The round was led by U.S. Venture Partners, co-led by Deerfield Management and joined by Baird Capital, St. Louis Park, Minn.-based NeoChord said. “NeoChord has established strong, clinical credibility with its current platform and has entrenched beating heart chordal repair as an important treatment option for the mitral toolbox. We are confident in the team’s ability to leverage their robust commercial experience in chordal repair with the...
Source: Mass Device - November 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured NeoChord Inc. Source Type: news

CardioMech taps medtech vet Nehm for CEO | Personnel Moves, November 5, 2018
 CardioMech taps medtech veteran Nehm for CEO Swedish mitral valve repair company CardioMech said today that it named medical device industry veteran Richard Nehm as president & CEO effective immediately. Nehm’s resume includes stints at Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) acquisition Tendyne and ATS Medical (acquired by Medtronic (NYSE:MDT)). CardioMech also named Spinal Stabilization Technologies president & CEO Mark Novotny as chairman. “There are more than 400,000 patients around the world that suffer from a leaky mitral valve due to prolapse or flail that are at a high-risk fo...
Source: Mass Device - November 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Business/Financial News Cantel Medical Corp. CardioMech Eos Imaging intersectent Medibio micronsolutions Personnel Moves Restoration Robotics Inc. Stereotaxis SurModics Inc. Vascular Insights Source Type: news

4Tech launches TriCinch coil system US feasibility study
4Tech said that it launched an FDA-approved U.S.-based early feasibility study of its TriCinch coil system intended to reduce tricuspid regurgitation, The first two successful implantations of the device were performed at Atlanta’s Piedmont Heart Hospital by Dr. Christopher Meduri, Dr. Vivek Rajagopal and Dr. Mani Vannan, the Ireland-based company said. “We are pleased to be the first center in the U.S. to implant the TriCinch Coil System. Both procedures went smoothly, and the device was easy to implant. Having a technology like the TriCinch Coil System in our structural heart toolkit allow...
Source: Mass Device - November 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials 4Tech Source Type: news

Philanthropic karma: Bernie Marcus tours future hospital site 24 hours after 'life-saving surgery' he helped bring to Atlanta
Bernie Marcus' philanthropic giving has gone full circle as he recently benefited from cardiovascular care he helped bring to Atlanta. Marcus, the billionaire co-founder of The Home Depot Inc. (NYSE: HD), underwent a transcatheter aortic valve replacement procedure on Oct. 16. It came six years after The Marcus Foundation gave $20 million to establish the Marcus Heart Valve Center at Piedmont Atlanta Hospital. Twenty-four hours after the "minimally invasive" procedure, he toured another piece of… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - October 30, 2018 Category: Pharmaceuticals Authors: Eric Mandel Source Type: news

Considering Transcatheter Aortic Valve Replacement?
Treatment TermsTAVR Sub-Title Questions to Ask Your Doctor About TAVR Overview Many doctors and hospitals now offer transcatheter aortic valve replacement for aortic valve disease, but their experience and success rates vary. Here ’s what you need to know before choosing where to have TAVR. Content Blocks CTA ButtonTAVR CTA Header Learn More About Hero Imageblog_tavr_1932x862.jpeg Preview Image Featured Doctors and Providers Jeffrey G. Gaca, MD Donald D. Glower Jr., MD J. Kevin Harrison, MD G. Chad Hughes IV, MD Todd L. Kiefer, MD Ryan P. Plichta, MD Richard M. Sabulsky Jr., PA Tina D. Tailor, MD ...
Source: dukehealth.org: Duke Health News - October 29, 2018 Category: Consumer Health News Authors: mf205 at duke.edu Source Type: news

Boston Scientific Keeps Us Guessing on Recent Legal Victory
Boston Scientific has a big decision to make in Germany, and the clock is ticking. Earlier this week, a German court sided with Boston Scientific in a patent case involving its transcatheter aortic valve replacement technology. The court decided that Edwards Lifesciences' Sapien 3 Ultra device infringed on a patent by Boston Scientific subsidiary Symetis that has to do with the fabric used on the valve seal. Edwards plans to appeal the decision and said the German court will hold a full hearing on the dispute next year. In the meantime, Boston Scientific has the right to prevent sales of the Sapien 3 Ultra in Germany. It i...
Source: MDDI - October 26, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Expect Boston Scientific to Keep Rounding Out Its Portfolio with M & amp;A
 Boston Scientific has been on quite the shopping spree in 2018. The Marlborough, MA-based company has announced eight acquisitions since the beginning of the year, plus a hefty investment in Millipede, which is likely to lead to an acquisition within the next year or so. Naturally, the company's aggressive M&A strategy has attracted attention from industry analysts who are eager to see if this spree will continue in 2019. During the company's third-quarter earnings call on Thursday, CFO Daniel Brennan said Boston Scientific still has a "tremendous amount" of financial flexibility. Loo...
Source: MDDI - October 25, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Boston Scientific claims win over Edwards Lifesciences in German TAVR spat
Boston Scientific (NYSE:BSX) today claimed a win in its global tussle with Edwards Lifesciences (NYSE:EW) over transcatheter aortic valve replacement patents. It’s the latest development in a long-running battle being fought on multiple legal fronts over the companies’ respective TAVR patent portfolios. In March 2017, a German court issued a mixed decision in the spat, less than a week after a U.K. patent court handed down a similar decision. A year later, the U.K. Court of Appeals upheld that ruling; across the pond that some month, Edwards won a round when the U.S. Pate...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Patent Infringement Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news

AHA: The Heart Problem This Stroke, Bypass Surgery Survivor Wasn't Expecting
MONDAY, Oct. 22, 2018 (American Heart Association) -- When Tom Broussard came out of quadruple heart bypass surgery, the then-59-year-old was just glad to have avoided a heart attack. So he didn't give much thought to the heart valve that surgeons... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - October 22, 2018 Category: General Medicine Source Type: news

Transcatheter Mitral Valve Repair Benefits Some With Heart Failure
FRIDAY, Oct. 19, 2018 -- Transcatheter mitral-valve repair results in a lower rate of hospitalization and lower all-cause mortality than medical therapy alone among patients with heart failure and moderate-to-severe secondary mitral regurgitation... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 19, 2018 Category: Pharmaceuticals Source Type: news