NETANYA, Israel, October 11, 2018 /PRNewswire/ — Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers, announced today that the company has received FDA 510(k) clearance for the TSP Crosser[TM] Transseptal Access System. […]
Coronary/Structural Heart
Neovasc Reducer™ Granted Breakthrough Device Designation from FDA
VANCOUVER, Oct. 10, 2018 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN) (TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the U.S. Food and Drug Administration (the “FDA”) […]
Bellerophon Provides Update on INOpulse® Phase 2b Clinical Program for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
WARREN, N.J., Oct. 09, 2018 (GLOBE NEWSWIRE) — Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today provided an update on the Company’s ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study (iNO-PF) evaluating INOpulse® in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), as […]
Edwards Announces Start Of U.S. Study Of Self-Expanding Transcatheter Heart Valve
IRVINE, Calif., Oct. 8, 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 it has commenced the U.S. pivotal trial that will study its self-expanding CENTERA transcatheter valve for severe, symptomatic aortic stenosis (AS) patients at intermediate […]
Vizient, Inc. Announces Moving Analytics as the 2018 Innovation Challenge Winner
IRVING, Texas–(BUSINESS WIRE)–Vizient, Inc. today announced Moving Analytics as the winner of its 2018 Innovation Challenge, an interactive competition between four early-stage growth health care companies. The competition was held on Wednesday, Oct. 3, during the opening session of the Vizient Clinical Connections Summit in Las Vegas. The Innovation Challenge is an interactive pitch […]
Eidos Therapeutics to Present Phase 2 Data for AG10 in TTR Amyloidosis Cardiomyopathy at the AHA 2018 Scientific Sessions in a Late-Breaking Featured Science Oral Presentation
SAN FRANCISCO, Oct. 05, 2018 (GLOBE NEWSWIRE) — Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today announced that results of its Phase 2 clinical trial studying AG10 in subjects with symptomatic transthyretin (TTR) amyloidosis cardiomyopathy (ATTR-CM) will be announced in a late-breaking featured science oral presentation at this year’s American Heart Association […]
V-Wave Announces Enrollment of First Patients in RELIEVE-HF Pivotal Trial of its Heart Failure Therapy
CAESAREA, Israel, Oct. 3, 2018 /PRNewswire/ — V-Wave Ltd. announced today that it has enrolled the first patients in its global, 500 patient pivotal study of its proprietary, minimally invasive implanted interatrial shunt device for treating patients with NHYA Class III and ambulatory Class IV symptomatic heart failure (HF). This randomized, controlled, double-blinded […]
Zenosense, Inc.: MIDS Medical Expands Technical Team
VALENCIA, SPAIN, Oct. 02, 2018 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Zenosense, Inc. (OTCQB: ZENO, “Zenosense”, the “Company”), a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce […]
PureFlow is a breakthrough technology in non-invasive cardiology and sports recovery; is now FDA 510K and MDD 93/42/ EEC cleared
NEW YORK, Oct. 2, 2018 /PRNewswire/ — Xtreem Pulse LLC is pleased to announce that PureFlow received 510Kclearance from the FDA for chronic stable angina that is refractory to optimal anti-anginal medical therapy and without option for revascularization. Intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased […]
Cardax Launches Human Clinical Trial Targeting Cardiovascular Inflammatory Health
HONOLULU, Oct. 2, 2018 /PRNewswire/ — Cardax, Inc. (OTCQB: CDXI) has launched its Cardiovascular Health Astaxanthin Supplement Evaluation (CHASE) clinical trial targeting cardiovascular inflammatory health. The first subject was dosed on September 19, 2018. The randomized, double-blind, placebo-controlled CHASE clinical trial will evaluate the effect of low-dose and high-dose ZanthoSyn®, Cardax’s premium astaxanthin supplement, on cardiovascular health, as measured […]


