Edwards, Medtronic heart valve systems prove worth in low-risk patients -studies
Non-invasive heart valve replacement systems from Medtronic Plc and rival Edwards Lifesciences Corp proved as good or better than open heart surgery in younger, more active patients for whom the surgical option was deemed low risk, according to trial results that had been scheduled to be presented on Sunday. (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Edwards, Medtronic heart valve systems prove worth in low-risk patients: studies
Non-invasive heart valve replacement systems from Medtronic Plc and rival Edwards Lifesciences Corp proved as good or better than open heart surgery in younger, more active patients for whom the surgical option was deemed low risk, according to trial results presented on Saturday. (Source: Reuters: Health)
Source: Reuters: Health - March 16, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

FDA ramps up scrutiny of materials in medical devices
(Image by Michael Longmire on Unsplash) The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ &ld...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news

FDA Approves New Indication for Valve Repair Device to Treat Certain Heart Failure Patients with Mitral Regurgitation
SILVER SPRING, Md., March 14, 2019 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitat... Devices, Interventional, Cardiology, FDA Abbott Vascular, MitraClip, mitral valve, mitral regurgitation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 14, 2019 Category: Pharmaceuticals Source Type: news

Neovasc advances warrant exchange from CardiAQ case
Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it issued in November 2017 to cover the $42 million balance from its loss in the CardiAQ lawsuit. The deals call for Neovasc to issue more than 496,000 shares in exchange for nearly 58.4 million warrants, which works out to 0.0085 shares per warrant. “We ...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Legal News Replacement Heart Valves Wall Street Beat neovasc Source Type: news

Edwards Makes Significant Moves in the Mitral Valve Space
Edwards Lifesciences bolstered its presence in the mitral valve space through a pair of transactions it announced Monday. The Irvine, CA based company invested $35 million in an exclusive right to acquire Corvia Medical and in addition the firm obtained certain assets of Mitralign for an undisclosed sum. Edwards investments come on the heels of Boston Scientific exercising its option to acquire the remaining shares of Millipede Inc. for $325 million. In addition, the Marlborough, MA-based company said a $125 million payment becoming available upon achievement of a commercial milestone. Tewksbury, MA-based Corvia Medical&ac...
Source: MDDI - March 11, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Edwards Lifesciences gets in on Corvia, Mitralign
Edwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets. Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said. &ldquo...
Source: Mass Device - March 11, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Mergers & Acquisitions Replacement Heart Valves Edwards Lifesciences Source Type: news

FDA Slammed for & #039;Hiding & #039; Device-Related Injury Reports
An investigative report claims FDA is hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program. Kaiser Health News reported that at least 1.1 million incidents have been reported through the alternative summary reporting (ASR) repository instead of being disclosed through the public database known as MAUDE. The Kaiser report focuses on the obscurity of the practice, which was created nearly 22 years ago, as MD+DI reported at the time. Back in 1997, FDA urged manufacturers of 12 types of medical devices to request permission to submit only summary ...
Source: MDDI - March 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Report: FDA hiding millions of adverse event reports from docs, public
The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News. Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the report. The summary reporting repository was originally created as an alternative for issues “well-known and well-documented with the FDA” and covers appr...
Source: Mass Device - March 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

A New Way of Looking at Things
It can get pretty crowded in an interventional procedure room, specifically for those places where image-guided therapy is being conducted. “Some of these procedures may require upwards of 15—or sometimes even 20—people in the suite,” said Barry T. Katzen, MD, founder and chief medical executive of Miami Cardiac & Vascular Institute, part of Baptist Health South Florida, in an interview with MD+DI. “And all of them have certain needs for technology, for space, for visualization, and things like that.” He noted th...
Source: MDDI - March 4, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Imaging Source Type: news

New joint Position Statement published on safe treatment of hyperprolactinaemia
The paper,“Echocardiography and monitoring patients receiving dopamine agonist therapy for hyperprolactinaemia: A joint position statement of the British Society of Echocardiography, the British Heart Valve Society and the Society for Endocrinology” was published today in bothClinical Endocrinology andEcho Research and Practice.This joint statement, written collaboratively by the key Societies with an interest in this condition, is important reading for any general medical professionals, as well as those in the cardiovascular and endocrine fields, that are involved in managing patients with hyperprolact...
Source: Society for Endocrinology - March 1, 2019 Category: Endocrinology Source Type: news

Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between Se...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news

LivaNova shares dip despite Q4, 2018 earnings beat
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker posting fourth quarter and full year 2018 earnings that topped expectations on Wall Street. The London-based company posted losses of $210.6 million, or $4.34 per share, on sales of $297 million for the three months ended December 31, seeing losses grow 88.5% while sales grew 6.7% compared with the same period during the previous year. Adjusted to exclude one-time items, earnings per share were $1.12, just ahead of the $1.10 consensus on Wall Street where analysts expected to see sales of $295 million, which the company topped. For the full yea...
Source: Mass Device - February 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

Aortic calcification: An early sign of heart valve problems?
Aortic valve calcification is a condition in which calcium deposits form on the aortic valve in the heart. These deposits can cause narrowing at the opening of the aortic valve. This narrowing can become severe enough to reduce blood flow through the aortic valve -- a condition called aortic valve stenosis. Aortic valve calcification may [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - February 27, 2019 Category: Databases & Libraries Source Type: news

Medical News Today: Study ties arthritis pain reliever to heart valve disease
An analysis of 8,600 electronic medical records has found a specific link between the use of the NSAID celecoxib (Celebrex) and aortic stenosis. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - February 26, 2019 Category: Consumer Health News Tags: Osteoarthritis Source Type: news

What do you know about heart murmurs?
Heart murmurs are sounds during your heartbeat cycle -- such as whooshing or swishing -- made by turbulent blood in or near your heart. These sounds can be heard with a stethoscope. A normal heartbeat makes two sounds like "lubb-dupp" (sometimes described as "lub-DUP"), which are the sounds of your heart valves closing. Heart murmurs [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - February 26, 2019 Category: Databases & Libraries Source Type: news

Swiss heart valve dev Novostia raises $7m
Swiss cardiovascular device developer Novostia said today it raised $6.5 million (CHF 6.5 million) to support its novel heart valve device. The Neuchâtel-based company said that the valve, which will be designed for use as both an aortic and mitral valve replacement, is designed from the company’s proprietary high-performance biocompatible polymer. Novostia said that the design, as well as the materials that make up the valve, eliminate the need for lifelong anticoagulant medication use or future replacements as well as the elimination of clicking noises often associated with the valves. “Our technology s...
Source: Mass Device - February 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured Replacement Heart Valves Wall Street Beat novostia Source Type: news

Study links Celebrex, heart valve calcification after earlier research declared drug safe
A well-known, four-year study found popular arthritis drug Celebrex no more dangerous for the heart than older drugs in its same classification - commonly called NSAIDs. Now, a big-data analysis of patient records at Vanderbilt University has found a link specifically between Celebrex and heart valve calcification. (Source: World Pharma News)
Source: World Pharma News - February 22, 2019 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news

Study links Celebrex, heart valve calcification after earlier research declared drug safe
(Vanderbilt University) On National Heart Valve Disease Awareness Day, Vanderbilt study disputes that Celebrex has no more impact on valves than older drugs in its class. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 22, 2019 Category: International Medicine & Public Health Source Type: news

LivaNova wins Japanese reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that it won national reimbursement through Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve intended to treat aortic valve disease. The London-based company said that the elastic Perceval valve’s sutureless design allows it to achieve optimal effective orifice area for improved hemodynamics. The company said that procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions. “With national reimbursement for Perceval, an innovative and trusted valve p...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Replacement Heart Valves LivaNova Source Type: news

CorMatrix launches FDA IDE Cor Tricuspid ECM cardiac valve trial
CorMatrix Cardiovascular said today that it launched a trial of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease, adding that the first patient in the trial has already been treated. The first procedure in the trial took place at the Francicscan Health Heart Center by a team led by Dr. Marc Gerdisch, Atlanta-based CorMatrix said. The patient, who was suffering from endocarditis, has returned home and is recovering well, the company added. “This first FDA study enrollment is a substantial step toward patients avoiding syn...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves CorMatrix Cardiovascular Inc. Source Type: news

Scientists discover new type of immune cells that are essential for forming heart valves
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the formation of healthy heart valves. The findings could pave the way for new treatments for heart valve disorders, which can be caused by congenital defects, aging or disease.Their study, led by Dr. Atsushi “Austin” Nakano, a UCLA associate professor of molecular, cell and developmental biology and member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, was published in the journal Developmental Cell.Building on previous research by Nakano, which showed that ...
Source: UCLA Newsroom: Health Sciences - February 21, 2019 Category: Universities & Medical Training Source Type: news

Scientists discover new type of immune cells that are essential for forming heart valves
(University of California - Los Angeles Health Sciences) UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the formation of healthy heart valves. The findings could pave the way for new treatments for heart valve disorders, which can be caused by congenital defects, aging or disease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 21, 2019 Category: International Medicine & Public Health Source Type: news

Edwards Lifesciences wins CE Mark for Pascal mitral repair device
Edwards Lifesciences (NYSE:EW) said late yesterday that it won CE Mark approval in the European Union for its Pascal transcatheter valve repair system intended to treat mitral regurgitation. The Pascal system is designed to reduce mitral regurgitation while maintaining native anatomy and features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area, the Irvine, Calif.-based company said. The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position, Edwards said. “Mitral v...
Source: Mass Device - February 20, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

3D printing yields custom-fit glasses for kids
Researchers from California have developed a method for creating individually...Read more on AuntMinnie.comRelated Reading: 3D printing unites radiology, otolaryngology 3D printing helps separate rare case of conjoined twins 3D printing technique improves heart valve sizing 3D-printed lungs improve patient understanding of surgery 3D printing boosts efficiency of rib fracture repair (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 20, 2019 Category: Radiology Source Type: news

Thousands of Britons could be saved from open heart surgery by 'clothes peg'
The implant – the size of a 2p coin – is now available to NHS patients suffering from heart valve disease, in which the valves that control the flow of blood through the heart function poorly and may leak. (Source: the Mail online | Health)
Source: the Mail online | Health - February 16, 2019 Category: Consumer Health News Source Type: news

Foldax Wins IDE for Surgical Aortic Heart Valve Trial
Foldax has received a nod from FDA to begin an early feasibility study of a surgical aortic heart valve. The Salt Lake City, UT-based company said its Tria surgical aortic heart valve is one of the first biopolymer heart valve platforms. The complete Tria heart valve platform will include valves developed for use in aortic, mitral, and tricuspid valve disease. “We look forward to introducing the Tria heart valve to patients in the U.S.”, Amit Patel, MD of the University of Utah, who will be serving as primary investigator in upcoming clinical trials, said in a release. “...
Source: MDDI - February 15, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Source Type: news

FDA green-lights early feasibility trial for Foldax ’ s Tria biopolymer heart valve
Early stage cardiovascular device company Foldax said today it won FDA investigational device exemption approval to launch an early feasibility study of its Tria surgical aortic heart valve. The valve uses a proprietary biopolymer material, dubbed LifePolymer, as well as a proprietary design, the Salt Lake City-based company said. Foldax touted that the Tria heart valve is intended as a “lifetime valve,” adding that it can provide hemodynamic performance and quality of life similar to natural human valves without the use of animal tissue or need for long-term anticoagulants. The Tria valve is intended for use i...
Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Food & Drug Administration (FDA) Replacement Heart Valves foldax Source Type: news

New 3D printer materializes entire 3D model at once
Researchers from California have developed a 3D printing technique that uses...Read more on AuntMinnie.comRelated Reading: 3D printing helps separate rare case of conjoined twins 3D printing technique improves heart valve sizing 'Bitmap' technique enhances quality, speed of 3D printing New technique changes colors of 3D-printed objects 3D printing technique optimizes fiber orientation (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 11, 2019 Category: Radiology Source Type: news

Safety board OKs continuation of CytoSorbents endocarditis trial
CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients. The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said. The study’s goal is to demonstrate improved hemodyna...
Source: Mass Device - February 6, 2019 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Regulatory/Compliance CytoSorbents Corp. Source Type: news

Study: Procedures with Abbott ’s Mitraclip show sustained low complication, mortality rates
Despite an increase in the number of procedures due to aging patients, minimally invasive mitral valve repair procedures using Abbott‘s (NYSE:ABT) Mitraclip system maintain a low mortality and complication rate, according to a new study from Mainz University Medical Center’s Center for Cardiology. Researchers in the Germany-based study examined more than 13,575 minimally invasive mitral valve procedures, touting the study as the largest of its kind to date. “Several studies with small groups of patients have already been published for the evaluation of the procedure with regard to the frequency of inserti...
Source: Mass Device - February 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Source Type: news

AtriCure launches CryoIce persistent AF ablation trial
AtriCure (NSDQ:ATRC) said today that it launched a new FDA investigational device exemption cleared trial of its CryoIce system exploring its use in treating persistent atrial fibrillation during concomitant open-chested cardiac surgery. The first patient in the trial has already been treated, the Mason, Ohio-based company said. The initial procedure took place at Takoma Park, Md.’s Washington Adventist Hospital. “Cryothermal energy has been a mainstay of surgical ablation for a long time. The ICE-AFIB IDE trial is the first of its kind designed to assess the safety and sustained effectiveness of cryotherm...
Source: Mass Device - February 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Surgical AtriCure Inc. Source Type: news

ASK THE GP: Why hasn ’t my wife been given an op for her leaky heart valve?
The Daily Mail's resident doctor answers your personal concerns in his weekly Good Health column. Today, he advises on leaky heart valves and prostate medication. (Source: the Mail online | Health)
Source: the Mail online | Health - February 5, 2019 Category: Consumer Health News Source Type: news

A New Way to Model the Heart Valve
The mitral valve repair space just got a little less complicated due to research from a team of engineers from The University of Texas at Austin. The group has developed a new noninvasive technique for simulating repairs to the mitral valve, which they say has levels of accuracy reliable enough for use in a clinical setting. The approach involves the use of computational modeling technology that could allow surgeons to provide patient-specific treatments. The engineers outlined their computational modeling technique for imaging mitral valve leaflets in recent issues of the International Journal for Numerical Methods in Bio...
Source: MDDI - February 1, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Source Type: news

New heart valve modeling technique enables customized medical care for patients
(University of Texas at Austin) Engineers at The University of Texas at Austin develop noninvasive way to simulate repairs to the heart's mitral valve allowing surgeons to provide patient-specific treatments. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - January 30, 2019 Category: Biology Source Type: news

Opioid epidemic fueling a rise in infection-related stroke
(American Heart Association) The opioid epidemic is fueling a steep rise in infection-related stroke hospitalizations. Injecting opioids, such as heroin, can introduce bacteria into the body which travels through the bloodstream to infect heart valves. Clumps of infected tissue can break off and travel to the brain, resulting in stroke. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 30, 2019 Category: International Medicine & Public Health Source Type: news

Neovasc jumps on Tiara trial news
Neovasc (NSDQ:NVCN) said today that it won approval to advance a clinical trial for its Tiara transcatheter mitral valve replacement, sending its share price up on Wall Street. The Vancouver-based company said it closed out the Phase I requirements for the 115-patient Tiara-II trial in the U.K. and Germany, after several reviews. The Clinical Events Committee looked at adverse events, the Data & Safety Monitoring Board reviewed the data and government regulatory and ethics committees reviewed the interim clinical report on 20 patients. Neovasc said the approval means Tiara-II can proceed in those countries with no...
Source: Mass Device - January 29, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat neovasc Source Type: news

FDA sets approval record, lays out 2019 strategy
FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015. Novel-device approvals in 2018 included an expanded approval of an automated insulin dosing system (Medtronic’s MiniMedG) to include children as young as age 7; the world’s smallest heart valve for newborns; the world’s first blood test (Banyan Biomarkers’ Brain Trauma Indicator) to evaluate mild traumatic brain inju...
Source: Mass Device - January 28, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Food & Drug Administration (FDA) News Well Banyan Biomarkers humanoptics idx Medtronic osteodetect Source Type: news

CorMatrix wins FDA IDE approval for Cor Tricuspid ECM cardiac valve trial
CorMatrix Cardiovascular said today that it won FDA investigational device exemption approval to launch an early feasibility study of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease. The Atlanta-based company touts its Cor Tricuspid valve as the first cardiac valve of its kind to be composed of an extracellular matrix, and said that its CorMatrix ECM has been used in more than 220,000 cardiac implants to date. “This important step for our patients and CorMatrix to create a valve that will mimic in all respects a normal valve...
Source: Mass Device - January 24, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves CorMatrix Cardiovascular Inc. Source Type: news

4D flow MRI, 3D printing improve congenital heart surgery
Planning a complex surgery for patients with congenital heart disease may require...Read more on AuntMinnie.comRelated Reading: 3D printing gives pediatric heart surgery a boost Heart valve-tracking algorithm boosts viability of 4D MRI 3D printing bolsters care for congenital heart disease Flexible 3D-printed heart replicates size, texture 4D MRI identifies abnormal flow patterns in thoracic aorta (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 23, 2019 Category: Radiology Source Type: news

Edwards Lifesciences settlement with Boston Scientific lets Neovasc off the hook
Last week’s legal win for Boston Scientific (NYSE:BSX) in its years-long patent battle with Edwards Lifesciences (NYSE:EW) was also a win for Neovasc (NSDQ:NVCN), that company said today. As part of a settlement deal worked out between Irvine, Calif.-based Edwards and Marlborough, Mass.-based Boston Scientific, the Federal Court of Canada dismissed a lawsuit brought by Edwards against Boston, in which Neovasc and LivaNova (NSDQ:LIVN) were named as co-defendants. Litigation over patent ownership between Edwards and Neovasc is not a part of the dismissal, Edwards said. The post Edwards Lifesciences ...
Source: Mass Device - January 22, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Legal News Replacement Heart Valves Boston Scientific Edwards Lifesciences LivaNova neovasc Source Type: news

FDA clears Abbott ’ s TactiCath Sensor Enabled AF contact force ablation cath
Abbott (NYSE:ABT) said today that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation. The newly cleared TactiCath SE is intended to provide precise images of the heart overlaid with real-time electrical activity information, the Chicago-area medtech company said. The catheter also features an ergonomic design also used in the company’s FlexAbility catheter intended to improve reach and maneuverability. “Cardiac ablation has become a front-line therapy in the fight against conditions like atrial fibrillation in part because o...
Source: Mass Device - January 22, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Featured Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

HighLife raises $36m Series B for mitral valve replacement
HighLife said today that it raised a Series B round worth more than $36 million for the transcatheter mitral valve replacement it’s developing. HighLife’s TMVR uses a ring around the diseased valve’s leaflets that’s designed to guide the replacement valve into position. It’s designed to be delivered through the inter-atrial septum, rather than via a trans-apical approach involving a puncture in the heart muscle. The Paris-based company said proceeds from the $36.4 million (€32 million) Series B round are earmarked for completing regulatory approval trials aimed at winning CE Mark app...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Replacement Heart Valves Wall Street Beat HighLife Source Type: news

LivaNova touts studies of its sutureless aortic valve
LivaNova (NSDQ:LIVN) said today that three separate, recently published studies highlight the performance and cost savings of its sutureless aortic valve, Perceval. The results from the Perceval Aortic Heart Valve Study in North America found that Perceval achieves positive safety and efficacy outcomes whether or not an open or minimally invasive surgical approach is used. The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers and was performed under an FDA Investigational Device Exemption. The results were published in the Journal of Thoracic and Cardi...
Source: Mass Device - January 17, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news

Abbott Finally Pulls the Trigger on Cephea Acquisition
It was only a matter of time before Abbott Laboratories exercised its option to acquire Cephea Valve Technologies, a company it first invested in back in 2015. The Abbott Park, IL-based company announced on Wednesday it would acquire the mitral valve maker for an undisclosed sum. Cephea's technology is being developed to provide an option for people whose diseased mitral valves need to be replaced. The artificial valve is designed to be delivered through a vein in the leg, forgoing the need for open-heart surgery. Replacement of the diseased mitral valve restores normal blood flow through the heart. "The acquisition o...
Source: MDDI - January 17, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Abbott to acquire mitral valve device maker Cephea Valve Tech
Abbott (NYSE:ABT) said today that it plans to acquire mitral heart valve replacement tech developer Cephea Valve Technologies for an undisclosed amount. The Chicago-area healthcare giant backed the Santa Clara, Calif.-based valve company in July 2015 and secured an option to purchase it outright, which it has now chosen to exercise. Cephea is developing mitral valve tech designed to be delivered through a vein in the leg and remove the need for open-heart surgery, Abbott said. Neither company has released any details of the acquisition. “The acquisition of Cephea builds on Abbott’s strong position in struc...
Source: Mass Device - January 16, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Mergers & Acquisitions Replacement Heart Valves Abbott Cephea Valve Technologies Source Type: news

Abbott To Acquire Cephea Valve Technologies, Inc.
Acquisition to further bolster Abbott's leading position in therapies for mitral valve disease, the most common type of heart valve ailment ABBOTT PARK, Ill., Jan. 16, 2019 -- (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) announced today... Devices, Interventional, Cardiology, Mergers & Acquisitions Abbott, Cephea Valve Technologies, Mitral valve, heart valve (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 16, 2019 Category: Pharmaceuticals Source Type: news

Abbott To Acquire Cephea Valve Technologies, Inc.
Acquisition to further bolster Abbott's leading position in therapies for mitral valve disease, the most common type of heart valve ailment (Source: Abbott.com)
Source: Abbott.com - January 16, 2019 Category: Pharmaceuticals Source Type: news

AHA: Infection as a Baby Led to Heart Valve Surgery for Teen
WEDNESDAY, Jan. 16, 2019 (American Heart Association) -- In middle school, Prince Pratt used to get short of breath walking between classes, walking up the stairs or when exercising. And he was gaining weight. His father, Reggie, simply thought his... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 16, 2019 Category: General Medicine Source Type: news

Abbott to acquire Cephea Valve Technologies, Inc.
Abbott (NYSE: ABT) announced today that it has exercised its option to purchase Cephea Valve Technologies, Inc., a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. Financial terms were not disclosed. Abbott provided capital and secured an option to purchase Cephea in 2015. (Source: World Pharma News)
Source: World Pharma News - January 16, 2019 Category: Pharmaceuticals Tags: Featured Abbott Business and Industry Source Type: news