510K Clearance for Glider PTA Balloon Catheter

FDA clearance has been granted for TriReme Medical Inc's. (TMI) newest product, the 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.

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

PAD represents a large unmet clinical need and a critical public health issue. Current balloon and stent therapies suffer from shortcomings in the challenging peripheral environment, evidenced by a low rate of acute and long term success.

"The Glider PTA 510K clearance is an important step towards sales of our products in the US market," says Eitan Konstantino, Ph.D., president and CEO of TMI. "This product complements our existing portfolio of Glider PTCA and Antares stent system that are approved and sold in Europe."

An advanced and differentiated product for the PAD therapy market, 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 powerful new tool to treat patients with PAD.