The Latest Cardiac and Vascular News
Centers for Medicare & Medicaid Services (CMS) confirms coverage of the device and routine care items and services PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart […]
Initiated PB2452 Phase 3 Trial for the Reversal of the Antiplatelet Effects of Ticagrelor MALVERN, Pa & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today reported financial results from the first quarter ending March 31, […]
New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature PARK CITY, Utah, May 12, 2020 /PRNewswire/ — Transit Scientific announced the FDA cleared the XO Cross® Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature. Microcatheters are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire […]
MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System came as a result of a comprehensive submission, including outcomes […]
Major milestone reached in journey toward FDA approval for potentially limb-saving treatment of peripheral artery disease WILMINGTON, Mass., May 12, 2020 /PRNewswire/ — Micro Medical Solutions (MMS) today announced the first implantation of the MicroStent vascular stent in the FDA randomized, multicenter pivotal clinical study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular […]
Highly Statistically Significant Improvements in NYHA Classification, Peak VO2, and LVOT Gradient Observed vs. Placebo Mavacamten Well Tolerated; Safety Results Comparable to Placebo U.S. Regulatory Submission Planned for Early 2021 MyoKardia to Host Conference Call at 8:00 a.m. ET BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) […]
Expands CytoSorb E.U. label that now includes the reduction of two major blood thinners, rivaroxaban (Xarelto®) and ticagrelor (Brilinta®), during on-pump cardiothoracic surgery with the goal of reducing serious perioperative bleeding complications MONMOUTH JUNCTION, N.J., May 12, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announces that CytoSorb® is […]
BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases, today announced that it has commenced a proposed underwritten public offering to sell $450.0 million in shares of its common stock. MyoKardia […]
EDEN PRAIRIE, Minn., May 12, 2020 (GLOBE NEWSWIRE) — CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the first quarter ended March 31, 2020, which included the following highlights: Revenue for the first quarter ended March 31, 2020, was $1.6 million, an increase of 34 percent compared to […]
First quarter revenue growth driven by continued strong uptake of the CGuard™ Embolic Prevention System (EPS) in the company’s major markets Management to host investor conference call today, May 12, at 8:30am ET TEL AVIV, Israel, May 12, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ […]
