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
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
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
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 res...
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 injury (concussion); technologie...
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 settlement with ...
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 of im...
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 approval in Europe, and fo...
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 Cardiovascula...
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 of Cep...
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 structura...
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
