Danvers, Mass .- ( BUSINESS WIRE ) -Abiomed (NASDAQ: ABMD) is a large target of 356 patients treated with Impella 5.5 with SmartAssist at 16 facilities in the United States and Germany. A large study announced that the survival rate at withdrawal from support was 79%. The majority of surviving patients recovered autologous heart function and did not require additional mechanical […]
Coronary/Structural Heart
Cardiovascular Systems, Inc. Announces Partnership With Chansu Vascular Techologies, LLC to Develop New Drug-Coated Balloon Technology
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) announced today that it has partnered with Chansu Vascular Technologies, LLC (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs). This partnership brings together CSI’s leadership in the treatment of calcified arterial lesions with Dr. Philippe Marco, a pioneer […]
Neovasc Announces 2021 Renewal of German Reimbursement NUB Status 1 Designation for Neovasc Reducer for Treatment of Refractory Angina
VANCOUVER and MINNEAPOLIS, MN, Feb. 02, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the German Institute for the Hospital Remuneration System(“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation once […]
BioCardia Update on Cell Therapy Product Development and 2021 Milestones
SAN CARLOS, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today provides an update on its cell therapy product development and 2021 milestones. BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical development for the treatment of […]
Edwards RESILIA Tissue Aortic Valve Demonstrates Favorable Safety and Efficacy at Five Years
AUSTIN, Texas, Jan. 31, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE clinical trial that demonstrate Edwards’ bioprosthetic surgical aortic valve with the company’s novel RESILIA tissue platform show favorable safety and hemodynamic performance through a median of five years follow-up. The data were presented at the […]
Matinas BioPharma Announces Topline Results from ENHANCE-IT Study of LYPDISO™ Against Vascepa®
– LYPDISO™ demonstrated a statistically significant 46% relative percent increase in EPA change from baseline over Vascepa® – – LYPDISO™ demonstrated a 39% relative difference in response over Vascepa in TG reduction – – Primary endpoint of percent change from baseline to end of treatment in triglycerides in the pharmacodynamic population did not meet […]
ANI Pharmaceuticals Announces Launch of Prazosin Hydrochloride (“HCl”) Capsules
BAUDETTE, Minn.–(BUSINESS WIRE)–ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the launch of Prazosin HCl Capsules USP, 1mg and 2mg, following the U.S. Food and Drug Administration’s (“FDA”) approval of the Company’s prior approval supplement application (“PAS”). The current annual U.S. market for Prazosin 1mg and 2mg […]
FEops Announces 2.000 Patients Modelled With FEops HEARTguide™
GENT, Belgium–(BUSINESS WIRE)–FEops, a digital health leader in personalized predictive planning for structural heart interventions, is proud to announce having modeled 2000 patients with FEops HEARTguide™ for the pre-operative planning of structural heart interventions. FEops HEARTguide™ is currently commercially available in the European Union, Canada and Australia for its TAVI […]
Micro Interventional Devices, Inc. ™ announces the submission of technical documentation for CE Marking for the MIA-T ™ Percutaneous Tricuspid Annuloplasty System
The application includes data from the STTAR clinical study with a one-year follow-up period. NEWTOWN, Pa. Jan. 29, 2021 / PRNewswire / – Micro Interventional Devices, Inc. ™ (MID) announced today that it has provided the technical documentation required for CE approval of its MIA-T ™ Percutaneous Tricuspid Annuloplasty System for tricuspid valve […]
Amarin Receives Positive CHMP Opinion for Icosapent Ethyl for Cardiovascular Risk Reduction
Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study European Commission decision on the Marketing Authorisation Application expected in April 2021 DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 29, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that in response to Amarin’s […]



