Summa Therapeutics, a specialty angioplasty balloon medical device company, announced today that its innovative line of injectable angioplasty balloon catheters has been cleared for marketing by the US Food and Drug Administration (FDA) for the treatment of peripheral artery disease.
Summa’s new Finesse Injectable angioplasty balloon catheters are cleared by the FDA for percutaneous transluminal angioplasty (PTA) treatment of peripheral artery disease including iliac, femoral, popliteal, infra-popliteal, renal arteries and AV dialysis access.
The Finesse injectable angioplasty balloon catheter differs from conventional angioplasty balloon catheters because it provides a port for the injection of radiopaque contrast material or other fluids in addition to performance of balloon angioplasty.
“We are delighted to receive FDA clearance for our Finesse angioplasty balloon product line,” said Timothy Murphy, Summa’s chief executive officer. “This achievement underscores our commitment to delivering innovative, minimally invasive vascular solutions that address critical unmet needs in the field of interventional medicine. We believe that the Finesse product line has the potential to revolutionise angioplasty procedures, providing physicians with an advanced toolset to treat patients with critical limb-threatening ischaemia [CLTI].”
The new angioplasty balloon catheter was designed to facilitate increasingly complex below-the-knee angioplasty procedures for patients with CLTI, a risk factor for leg amputation. The Finesse Injectable angioplasty balloon catheter is the first injectable angioplasty balloon catheter designed to treat small arteries in the calf. The combination of a diagnostic catheter and angioplasty balloon catheter in one device is expected to reduce catheter exchanges, lower contrast doses, and shorten procedure times, and lead to better patient outcomes and lower costs. Summa plans to launch the product line in the fourth quarter of 2023 in the USA.
