Other News

FDA approves new device to improve symptoms in patients with advanced heart failure

SILVER SPRING, Md., Aug. 16, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device […]

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is […]

Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to the treatment […]

MyoKardia Launches 2nd Annual MyoSeeds™ Research Grants Program to Advance Independent Research in Heart Disease

Pre-Application Letters of Intent are Due September 13 for the 2019-2020 Funding Cycle SOUTH SAN FRANCISCO, Calif., Aug. 15, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. today announced the launch of the 2nd Annual MyoSeeds™ Research Grants Program, an initiative to support original, independent research in the biology and underlying mechanisms of cardiomyopathies […]

preCARDIA Enrolls First Patient in Early Feasibility Study

Company initiates the VENUS-HF study in patients with Acute Decompensated Heart Failure (ADHF) ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), has enrolled the first patient in the VENUS-HF Early Feasibility Study at Tufts Medical […]

Cardax Files Registration Statement for Proposed $15 Million Follow-On Offering

– Maxim Group to serve as sole book running manager on a firm commitment basis – Funds to be used primarily for pharmaceutical development – Concurrent Nasdaq uplisting planned HONOLULU, Aug. 14, 2019 /PRNewswire/ — Cardax, Inc. (OTCQB:CDXI) announced today that it filed a registration statement on Form S-1 with the Securities […]

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent (AMDS)

Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

CAESAREA, Israel, Aug. 15, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF). V-Wave’s minimally invasive, implanted interatrial […]

Renovacor Closes $11 Million Series A Financing to Advance First Gene Therapy for a Rare Cardiovascular Disease

– Funding supports preclinical development through IND submission for its BAG3 gene therapy, the first gene replacement product for genetic forms of dilated cardiomyopathy – Company announces leadership team and board of directors with leading scientists, physicians and experienced venture investors in cardiovascular and gene therapy fields August 14, 2019 10:11 AM […]