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FDA Clears TriReme Medical Glider PTA Balloon Catheter

TriReme Medical (TMI) has received FDA clearance for Glider balloon catheter for percutaneous transluminal angioplasty (PTA) of lesions in the peripheral vasculature including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries.

An advanced and differentiated product for the PAD therapy market, TMI’s Glider PTA catheters have shaft construction reinforced for torque transmission and an a-traumatic tapered tip configuration. Designed to be delivered through the complex peripheral anatomy to cross long and tight lesions and to restore blood flow in the vessels, Glider PTA catheters provide physicians a new tool to treat patients with PAD.

Approximately 12 million Americans are affected by peripheral arterial disease (PAD). Those patients suffer from chronic pain, mobility limitations and debilitating quality of life. Left untreated, PAD can lead to a limb loss and even to death, according to the company.

Eitan Konstantino, president and chief executive officer of TMI, said: “The Glider PTA 510K clearance is an important step towards sales of our products in the US market. This product complements our existing portfolio of Glider PTCA and Antares stent system that are approved and sold in Europe.”

California-based TMI is a privately held medical device company dedicated to the development, manufacturing, and commercialization of next generation percutaneous devices for the treatment of complex coronary and peripheral arterial disease.