Tag: PAD

VentureMed Group Raises $15 Million Series B Equity Financing

TOLEDO, Ohio, Aug. 15, 2017 /PRNewswire/ — VentureMed Group®, Inc., (“VMG” or the “Company”) a medical device company developing and commercializing next-generation endovascular products to treat patients suffering from peripheral artery disease (PAD), today announced it had raised $15 million in new equity financing. The Series B Round was led by new investor Endeavour […]

QT Vascular begins enrollment in US pivotal study of its drug-coated peripheral balloon

SINGAPORE, July 31, 2017 /PRNewswire/ — QT Vascular Ltd., together with its subsidiaries (the “Company”), announced it has started enrollment in its United States (“US“) pivotal clinical study. The study will evaluate the Company’s drug coated balloon (“DCB“), the Chocolate Touch®, for use in superficial femoral and popliteal arteries with the intention of obtaining […]

Spectranetics (SPNC) Secures FDA Approval of Stellarex Drug-Coated Balloon

COLORADO SPRINGS, Colo., July 26, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) today announced receipt of U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) of the Stellarex™ drug-coated balloon (DCB), designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease […]

SurModics (SRDX) Receives IDE Approval To Initiate Pivotal Trial Of The Surveil Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil™ drug-coated balloon (DCB). The randomized […]

BIOTRONIK US Announces Pivotal Trial Results of the Pulsar-18 Stent with 4-French Delivery System

NEWS PROVIDED BY BIOTRONIK Jul 03, 2017, 10:00 ET LAKE OSWEGO, Ore., July 3, 2017 /PRNewswire/ — BIOTRONIK today announced the results of the BIOFLEX-I clinical study and availability of Pulsar®-18 for the treatment of patients with peripheral artery disease (PAD). Pulsar-18 is the only superficial femoral artery (SFA) self-expanding stent approved by the FDA with […]

Heart Endovascular & Rhythm of Texas Begins First Commercial, FDA-Cleared, In-Patient Use of DABRA™ to Treat Peripheral Artery Disease

SAN ANTONIO–(BUSINESS WIRE)–Today, the Heart Endovascular & Rhythm of Texas announced its latest collaboration with Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, to use its groundbreaking DABRA™ System for the treatment of Peripheral Artery Disease (PAD) in order to combat the growing rise of diabetic […]

Shockwave Medical Announces U.S. Commercial Availability Of Lithoplasty System And Enrollment Of First Patient In DISRUPT PAD III Global Clinical T

FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced two milestones for its Lithoplasty® System for the treatment of calcified plaque in patients with peripheral artery disease (PAD): enrollment of the first patient in the global DISRUPT PAD III clinical trial at the Medical […]

RA Medical’ DABRA Begins First Commercial, FDA-Cleared, In-Patient Use

NEW ORLEANS, La.–(BUSINESS WIRE)–Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, today announced the commercial launch in the United States of the Company’s groundbreaking DABRA™ System for the treatment of Peripheral Artery Disease. This follows FDA clearance earlier this week. Dr. Athar Ansari of the California […]

FDA Grants Market Clearance to RA Medical’s New PAD System

CARLSBAD, Calif.–(BUSINESS WIRE)–In an effort to battle Peripheral Artery Disease (PAD), the leading cause of limb amputations, the Food and Drug Administration (FDA) announced today that it has granted market clearance to Ra Medical Systems, makers of excimer lasers and catheters for cardiovascular and dermatological diseases, for the Company’s groundbreaking […]