Other News

SentreHEART Receives CE Mark for LARIAT-RS™ 50mm and Expanded Indication for Left Atrial Appendage Exclusion

REDWOOD CITY, Calif.–(BUSINESS WIRE)–SentreHEART, Inc., announced it has received CE Mark for the LARIAT-RS™ 50mm as well as expanded labeling for the LARIAT-RS for left atrial appendage (LAA) exclusion. The new 50mm device along with the 45mm LARIAT-RS is now available for sale in Europe. The LARIAT-RS (LARIAT) device is […]

Abiomed Announced Q4 FY 2019 Revenue of $207 Million and 31.6% Operating Margin

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported fourth quarter fiscal 2019 revenue of $207.1 million, an increase of 19% compared to revenue of $174.4 million for the same period of fiscal 2018. For fiscal year 2019, total revenue was $769.4 […]

Cardiovascular Systems, Inc. Reports Fiscal 2019 Third-Quarter Financial Results

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today reported financial results for its fiscal third quarter, ended March 31, 2019. CSI’s third-quarter revenues were $63.3 million, an increase of […]

First-of-its-Kind Large Access Dilator Launches in U.S., Following Cleveland Clinic Case

TORONTO, May 2, 2019 /PRNewswire/ – Baylis Medical announced today the U.S. launch and first clinical use of its ExpanSure™ Transseptal Dilation System, used in a left-atrial appendage (LAA) closure case performed at the Cleveland Clinic, in Cleveland, Ohio. The ExpanSure dilator combines a sheath and dilator into a single tool, and facilitates larger […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From FDA for Its MagicTouch Sirolimus Coated Balloon

TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]

FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive […]

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]

Sotera Wireless to Showcase Its Life-Saving ViSi Mobile 1.5G at the 2019 IHI Patient Safety Congress

SAN DIEGO–(BUSINESS WIRE)–Sotera Wireless, maker of the ViSi Mobile® Surveillance Monitoring System will be exhibiting at the Institute for Healthcare Improvement Patient Safety Congress (IHI) on May 15-17 in Houston, TX. The IHI Patient Safety Congress brings together people who are passionate about providing the highest quality care and patient […]

GENETIC-AF Phase 2B Trial Results Published in the Journal of American College of Cardiology: Heart Failure

WESTMINSTER, Colo., May 01, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population” was published in JACC: Heart Failure, a journal […]