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 […]
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’(NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and overall performance within […]
Transcatheter mitral valve tech dev CardioMech AS raises $3m
Early stage cardiovascular intervention tech developer CardioMech AS said today that it raised $2.5 million in a convertible note financing round. The Oslo-based company said that the round was significantly oversubscribed, and included investments from experienced angel investors. CardioMech is developing a transcatheter alternative to cardiac surgery for the placement of artificial chords for the […]
Long-term stroke risk cut by carotid surgery or stenting
An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure. Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s […]
HeartFlow publishes findings from consumer survey
HeartFlow this week published the findings of a 1,500-person consumer survey, reporting that just 29% of respondents knew that heart disease is the No. 1 cause of death among adults in the U.S. Half of the survey’s participants said that breast cancer is the leading cause of death among women, rather than heart disease. “We […]
Intracardiac ECG tech dev NuVera Medical raises $15m
Medtech incubator Shifamed portfolio company NuVera Medical said today it closed a $15 million financing round slated to support its real-time 3D intracardiac echocardiography technology platform. The round was led by Cormorant Asset Management and joined by the Capital Partnership, Lilly Asia Ventures and other existing shareholders, the Campbell, Calif.-based company said. “We are pleased to […]
Leviticus Cardio, Jarvik Heart unveil wireless LVAD
Jarvik Heart and Leviticus Cardio yesterday unveiled a new collaborative wirelessly-powered left ventricular assist device and touted its recent first-in-human use. An article on the new heart and its first implantation was recently published in the Journal for Heart and Lung Transplantation, the companies said. The device, dubbed the Fully Implanted Ventricular Assist Device (FIVAD), […]
Thoratec inks $12m investor suit settlement deal
Abbott (NYSE:ABT) owned Thoratec is seeking approval for a $11.9 million deal to settle class action claims that it and some of its officers hid facts about its Heartmate II heart pump’s thrombosis rate that would have negatively affected share prices, according to recently released court documents. Investor Bradley Cooper originally brought the suit against the company […]
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 […]
J&J’s Biosense Webster launches IDE-cleared Qdot Micro RF ablation trial
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said yesterday it launched a new FDA investigational device exemption study of its Qdot Micro radiofrequency ablation catheter exploring its use in treating symptomatic drug-refractory paroxysmal atrial fibrillation. The first patient in the trial has already been treated, with the procedure taking place at NYU Langone Health’s Heart Rhythm Center, the […]
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 […]
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