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 platf...
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 synthet...
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 the embr...
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 valve...
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 hemodynamic stab...
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 inserting t...
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 cryothermal a...
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 4, 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