Author: Ken Dropiewski

Aziyo Launches CanGaroo Bio Envelope for Subcutaneous Implantable Cardioverter-Defibrillators

SILVER SPRING, Md.–(BUSINESS WIRE)– Aziyo Biologics, a fully integrated regenerative medicine company, today announced the launch of a new CanGaroo Bio Envelope specifically for use with subcutaneous implantable cardioverter-defibrillators (S-ICDs). This is the only cardiac implantable electronic device (CIED) envelope available for use with S-ICDs. CanGaroo is a natural extracellular matrix (ECM) scaffold that […]

Neovasc Jumps on FDA Nod for Clinical Trial

VANCOUVER, Nov. 6, 2017 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company“) (NASDAQ, TSX: NVCN) announced that it has received approval of the U.S. Food and Drug Administration (“FDA”) to initiate the COSIRA-II IDE pivotal clinical trial.  The trial’s purpose will be to demonstrate the safety and effectiveness of the Company’s novel Reducer system […]

BioCardia Announces Reverse Stock Split and Release of Indemnity Holdback Shares

SAN CARLOS, Calif.–(BUSINESS WIRE)– BioCardia, Inc.[OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced a reverse split of its common stock, $0.001 par value, at a ratio of 1 for 12, effective November 2, 2017 (the “Effective Date”). The company’s common stock will begin […]

Mitralign Release: SCOUT I Study Using Trialign System for Transcatheter Tricuspid Repair Continues to Show Positive Outcomes at 1 Year

DENVER–(BUSINESS WIRE)– Mitralign, Inc.., an innovative developer of transcatheter tricuspid and mitral valve repair solutions, today released 1 year follow up data from the SCOUT I Early Feasibility Study designed to evaluate the performance of its Trialign™ System. The data presented by Rebecca Hahn, M.D., New York-Presbyterian/Columbia University Medical Center, continue […]

Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time

DUBLIN and DENVER – November 2, 2017 – Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve […]

Five-year Follow-up Data Demonstrate the WATCHMAN™ Left Atrial Appendage Closure Device Provides Stroke Risk Reduction Comparable to Warfarin Therapy

DENVER and MARLBOROUGH, Mass., Nov. 2, 2017 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced final five-year outcomes data from the PREVAIL study of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device today during a late-breaking clinical trial session at the 29th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Denver. The […]

Imricor and MiRTLE Medical Announce Joint Development Agreement to Deliver 12-Lead ECG for Real-Time MRI-Guided Cardiac Ablations

MINNEAPOLIS–(BUSINESS WIRE)–Imricor and MiRTLE Medical announce a joint development agreement to fully integrate MiRTLE’s MR compatible 12-lead ECG system with Imricor’s Advantage-MR™ EP Recorder/Stimulator System. This integration, along with Imricor’s MR compatible catheters, will allow physicians to perform complex cardiac ablations, such as for treating ventricular tachycardia and atrial fibrillation, under real-time MRI-guidance. […]

4C Medical’s Novel Transcatheter Mitral Valve Presented at TCT 2017 Shark Tank Innovation Competition

BROOKLYN PARK, Minn., Nov. 2, 2017 /PRNewswire/ — 4C Medical Technologies, Inc., a developer of minimally invasive technologies for structural heart disease, today announced that its medical device for mitral regurgitation (MR) was presented at the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held October 29-November 2, […]

Medline to Acquire Centurion Medical Products for Undisclosed Sum

NORTHFIELD, Ill.–(BUSINESS WIRE)– Medline and Centurion Medical Products today announced an agreement for Medline to acquire the Williamston, Michigan-based medical supplies manufacturer in a transaction that will close later this year. Once the acquisition closes, Medline will have a full set of vascular access products that complement its minor procedure tray offerings and its […]

Medtronic Shows Off Early Intrepid TMVR Data

DUBLIN and DENVER – November 1, 2017 – Medtronic (NYSE:MDT) today presented positive data for its self-expanding Intrepid(TM) transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. Presented as a First Report Investigation at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting and simultaneously published in the Journal of the American […]