Author: Ken Dropiewski

Bay Area’s Cardiva Med Banks $30 Million

Cardiva Medical Raises $30 Million – >Financing to Fuel Commercial Growth of VASCADE Vascular Closure System and Development of Next Generation Products for Vascular Closure SANTA CLARA, Calif., March 14, 2017 /PRNewswire/ — Cardiva Medical, an innovator in the field of vascular closure, today announced that the company has completed […]

AV Medical’s Chameleon receives expanded indication to include infusion of diagnostic or therapeutic fluids

TEL AVIV, Israel–(BUSINESS WIRE) AV Medical Technologies announced on 27 February 2017 that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids. “The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access […]

Medtronic (MDT) Snags FDA Approval for First of Its Kind Melody Transcatheter Pulmonary Valve

Press Release  View printer-friendly version Medtronic Melody Transcatheter Pulmonary Valve First of Its Kind to Receive FDA Approval for Implantation in Failed Surgical Pulmonary Heart Valves Newly Approved Indication in U.S. Expands Treatment Options to More Patients with Congenital Heart Disease DUBLIN – March 14, 2017 – Medtronic plc (NYSE: […]

Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of Spectre™ Guidewire

View source version on businesswire.com:  http://www.businesswire.com/news/home/20170314005152/en/ Teleflex Incorporated (TFX), a leading global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and U.S. commercial launch of the Spectre Guidewire. The Spectre Guidewire is engineered with a smooth stainless steel-to-nitinol dual-core […]

Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology

Press Release DUBLIN – Mar. 9, 2017 – Medtronic plc (NYSE: MDT) today announced the launch of the IN.PACT(TM) BTK study to evaluate the effectiveness of using a drug-coated balloon (DCB) in patients with below-the-knee (BTK) peripheral arterial disease (PAD). This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty […]

Tryton medical receives FDA approval for Tryton side branch stent to treat significant coronary bifurcation lesions

PCRonline/News/Industry Press Releases Tryton stent is the first dedicated bifurcation device to receive regulatory approval in the U.S. Cordis to be exclusive U.S. distributor of the Tryton stent. DURHAM, N.C. – Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced the U.S. Food […]

Keystone Heart Applauds FDA Advisory Panel for Recognition of The Need for Cerebral Protection Following TAVR

CAESAREA, Israel and TAMPA, Fla., Feb. 27, 2017 /PRNewswire/ — Keystone Heart Ltd., an emerging medical device company focused on developing cerebral embolic protection devices for patients undergoing cardiac procedures, applauds the members of the FDA’s Circulatory System Devices Panel that convened this past week for their acknowledgement of the […]

CEO and Co-founder of Renova Therapeutics to present at Novel Cardiovascular Therapeutics Summit

SAN DIEGO, Feb. 27, 2017 /PRNewswire-USNewswire/ — Renova™ Therapeutics, a biotechnology company developing gene therapy treatments for congestive heart failure and type 2 diabetes, announced that the company’s CEO and Co-founder, Jack W. Reich, Ph.D., will be speaking at the Novel Cardiovascular Therapeutics Summit in San Francisco on February 28, […]