TriReme Medical has received FDA clearance for its 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.
This product complements TriReme’s portfolio of Glider PTCA and Antares stent system that are approved and sold in Europe.
The Glider Balloon Catheter is a dilatation catheter designed to overcome the limitations of conventional balloon catheters in treating complex disease. It can be used to optimise results while treating bifurcation lesions with the Antares Coronary Stent System or with any other conventional stent. It may also be used to dilate highly-stenosed lesions.
According to Eitan Konstantino, Ph.D., president and chief executive officer of the company, this clearance is a significant step towards sales of company’s products in the US market.
The company shared that around 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.
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
