Coronary/Structural Heart

MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions

NYON, Switzerland, March 4, 2021 /PRNewswire/ — MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions […]

Orsini Specialty Pharmacy Selected By Sarepta Therapeutics As A Limited Distribution Partner For AMONDYS 45 (casimersen)

ELK GROVE VILLAGE, Ill., March 4, 2021 /PRNewswire/ — Orsini Specialty Pharmacy, the leading independent specialty pharmacy focused on rare diseases and gene therapies, announced today that it has been selected by Sarepta Therapeutics, Inc. as a limited distribution partner for AMONDYS 45 (casimersen). AMONDYS 45 is indicated for the treatment of […]

BERLIN HEALS Announces results of first-in-human study for its Implantable C-MIC device for the Treatment of Heart Failure with Electrical Microcurrent and the Launch of a pivotal CE Mark Study

BERLIN and ZUG, Switzerland, March 04, 2021 (GLOBE NEWSWIRE) — BERLIN HEALS, a company dedicated to developing and offering novel and life-saving treatments for patients suffering from heart failure, announces results of a first-in-human study published in ESC Heart Failure, in patients with dilated cardiomyopathy for its proprietary C-MIC device. The […]

MEDCERT Enables the Use of the Single Access Procedure with Impella CP Introducer Sheaths in Europe

At Abiomed’s European headquarters in Aachen, Germany, Impella heart pumps have been developed and produced for more than 20 years to stabilize and recover the human heart. The single access procedure enables the treating physician not only to place Impella heart pumps in the ventricle via the 14 French Impella […]

Innovative Cardiovascular Solutions Announces Successful First Cases in European Clinical Study of its Next Generation EMBLOK™ Embolic Protection System

MILAN, March 2, 2021 /PRNewswire/ — Innovative Cardiovascular Solutions (ICS), a privately held medical device company developing the most complete comprehensive solution to embolic protection for structural heart and vascular interventions, announced today the success of its first European clinical cases using the next generation of the EMBLOK™ Embolic Protection System in patients […]

New Analysis of REVERSE Trial Reveals Benefits of CRT for More Patients with Heart Failure

JACC: Clinical Electrophysiology: Findings Highlight Need to Better Classify Heart Failure Outcomes DUBLIN, March 2, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced new results from the landmark REVERSE trial, evaluating outcomes of cardiac resynchronization therapy (CRT) for patients with mild heart failure (HF). This new […]

TransMedics Announces Scheduling of OCS Heart FDA Advisory Committee Meeting

ANDOVER, Mass., March 1, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that the FDA’s Office of Health Technology 2 (Cardiovascular Devices) has communicated its intent to hold a Circulatory Systems Device […]

Neovasc Comments on Clinical Cardiology Journal Publication

VANCOUVER and MINNEAPOLIS, March 02, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the journal Clinical Cardiology has published an article entitled, “Long-term outcomes of patients undergoing coronary sinus reducer implantation – A multicenter study.” The article, authored by Maayan Konigstein, M.D., Tel […]

LEXEO Therapeutics Announces License Agreement and Consolidation of Comprehensive Pre-clinical Data Package to Support Cardiac Friedreich’s Ataxia Gene Therapy Program (LX2006)

LEXEO completes license of all intellectual property rights and pre-clinical data associated with Adverum Biotechnologies’ investigational Friedreich’s ataxia program Pre-clinical research licensed from academic partners and data from Adverum’s program now consolidated to support the advancement of LX2006; Phase 1 clinical trial expected to initiate in 2021 NEW YORK, March 01, 2021 (GLOBE NEWSWIRE) — LEXEO […]