CorCinch HFrEF Study Evaluating Safety of AccuCinch Ventricular Repair System in Heart Failure Patients SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of enrollment in its CorCinch HFrEF […]
Author: Ken Dropiewski
Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (the “Company”), a developer and marketer of innovative treatments for aortic disorders, announced today the grant of an inducement equity award to a newly hired employee (the “Awardee”). The award was approved by the Company’s Compensation Committee, which is comprised of independent directors, on […]
MedAlliance Receives CE Mark Approval for SELUTION SLR™ Sirolimus Drug Eluting Balloon for Endovascular Applications
3 February 2020 – MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of peripheral arterial disease. This approval applies to sizes from 2.0 x 20mm to 7.0 x 150mm. This award was supported by two-year […]
Neovasc Announces Renewal of German Reimbursement NUB Status 1 Designation for Neovasc Reducer for Treatment of Refractory Angina
VANCOUVER, Jan. 31, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that the Institut für […]
Itamar™ Medical Announces Upsizing and Pricing of Public Offering of American Depositary Shares
CAESAREA, Israel, Jan. 30, 2020 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (Nasdaq: ITMR) (TASE: ITMR), a medical technology company focused on the development and commercialization of non-invasive medical devices to aid in the diagnosis of respiratory sleep disorders, today announced the upsizing and pricing of its public offering of 2,545,450 American Depositary […]
Edwards Lifesciences Reports Fourth Quarter Results
IRVINE, Calif., Jan. 30, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended December 31, 2019. Fourth Quarter Results and Outlook Q4 sales grew 20% to $1.2 billion; underlying1 sales grew 19% Q4 TAVR sales grew […]
Esperion Announces Positive CHMP Opinion for the Marketing Authorization Application for the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia
– Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet is an Oral, Once-Daily, Non-Statin Medicine that Lowers Bad Cholesterol with a First-in-Class Mechanism – – Positive CHMP Opinion is Based on the Completed Pivotal Phase 3 Fixed Dose Combination Tablet LDL-Cholesterol Lowering Program – – European Commission Decision on the Marketing Authorisation Application […]
CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet as treatments for hypercholesterolaemia
Bempedoic acid is an oral, once-daily ATP citrate lyase inhibitor that reduces cholesterol synthesis in the liver. This unique mechanism of action is complementary to statins and other lipid-lowering therapies1 Positive CHMP opinions are based on a global clinical trial programme demonstrating consistent LDL-C lowering across a range of patient […]
ABBOTT’S TENDYNE™ DEVICE RECEIVES WORLD’S FIRST CE MARK FOR TRANSCATHETER MITRAL VALVE IMPLANTATION
– First-of-its-kind technology addresses critical need to eliminate mitral regurgitation when surgery or mitral repair is not an option – Tendyne valve provides relief from heart failure symptoms and quality-of-life improvement in high-surgical-risk patients – Together with MitraClip™, Tendyne expands Abbott’s market-leading portfolio of innovative minimally invasive mitral valve solutions […]
Medtronic Receives CE Mark for Cobalt™ and Crome™ Portfolio of BlueSync™-Enabled Implantable Defibrillators, Cardiac Resynchronization Therapy-Defibrillators
Next Generation Technology Includes Features that Automatically Adjust to Patient Needs, and Offers Physicians Heart Failure Diagnostic Insights DUBLIN, Jan. 30, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received CE (Conformité Européenne) Mark for its Cobalt™ and Crome™ portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators […]



