Coronary/Structural Heart

Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved By Medsafe In New Zealand

Marks 7th Regulatory Approval for VASCEPA®/VAZKEPA® Franchise in Key International Markets Since 2022 DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events […]

JACC Publication Guides Use of CareDx’s HeartCare Transplant Rejection Surveillance in Clinical Practice

Guide Helps Transplant Centers Continue the Evolution from Endomyocardial Biopsies to Noninvasive Surveillance Using AlloMap GEP and AlloSure dd-cfDNA BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced […]

XyloCor Therapeutics Reports Positive Topline Safety and Efficacy Results from Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina

-No serious adverse events related to drug product were reported -Patients demonstrated improvements in exercise capacity and reductions in episodes of chest pain -Cardiac imaging results provide mechanistic evidence supporting the therapeutic potential of XC001 in cardiovascular disease WAYNE, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies […]

MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SELUTION SLR Coronary Sirolimus DEB Study

GENEVA, Jan. 25, 2023 /PRNewswire/ — The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon […]

New Initiative Aims to Reverse the Alarming Rise in Cardiovascular Deaths

Cardiovascular Disease is the Number One Cause of Death Nationwide WASHINGTON, Jan. 25, 2023 /PRNewswire/ — The number of cardiovascular deaths is on the rise again after a decades-long decline. As organizations working to advance cardiovascular health and the interests of medically underserved communities, the Foundation of the National Lipid Association and the […]

FDA Agrees to Expanded Access Program for the BioVentrix® Revivent TC® System for the Treatment of Ischemic Heart Failure

Treatment IDE Will Provide Opportunity to Treat Additional Patients in the US SAN RAMON, Calif., Jan. 24, 2023 /PRNewswire/ — BioVentrix®, Inc., a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process of progressive heart […]

CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

PRINCETON, N.J., Jan. 23, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received regulatory approval from Health Canada allowing inclusion of Canadian sites into the pivotal Safe and Timely Antithrombotic Removal […]

Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation

PONTE VEDRA, Fla., Jan. 23, 2023 /PRNewswire/ — Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred […]

Able Medical Announces Launch of Valkyrie® Looped Sternotomy Sutures

A stainless-steel looped wire suture used to approximate sternums. MARQUETTE, Mich.–(BUSINESS WIRE)–Able Medical Devices today announced the launch of Valkyrie® Looped Sternotomy Sutures. The stainless-steel looped wire sutures are used to close a patient’s chest after open heart surgery. When compared to traditional wire sutures, the Valkyrie Looped Suture doubles […]

Intermountain Healthcare and Story Health Partner to Transform Specialty Care for Patients with Heart Failure

Partnership to Improve Access to High-Quality Continuous Specialty Care with Story Health’s Innovative Platform CUPERTINO, Calif., Jan. 19, 2023 /PRNewswire/ — Intermountain Healthcare, a leading health system of 33 hospitals in seven states, and Story Health, a health technology and services company that provides scalable specialty care beyond the clinic, have entered into a […]