Summa Therapeutics Second-Generation Finesse Injectable Angioplasty Balloon Catheter Cleared by FDA

July 17, 2024—Summa Therapeutics announced that the second generation of the company’s Finesse Injectable angioplasty balloon catheters has been cleared by the FDA for percutaneous transluminal angioplasty treatment of peripheral artery disease, including infrapopliteal arteries among others. The company noted that in addition to its performance of balloon angioplasty, the Finesse Injectable device provides a port for the injection of radiopaque contrast material or other fluids.

The company stated that it plans to launch the redesigned product line in the fourth quarter of 2024 in the United States and in select markets around the world.

According to Summa Therapeutics, the Finesse Injectable device was designed to facilitate complex below-the-knee angioplasty procedures for patients with chronic limb-threatening ischemia. Combining a crossing catheter, diagnostic catheter, and angioplasty balloon catheter in one device, the Finesse Injectable is intended to reduce catheter exchanges, lower contrast doses, and shorten procedure times.

Design improvements in the second-generation version include moving the injection exit holes closer to the angioplasty balloon, adding catheter working lengths of 65 and 100 cm, and modifying the injection lumen adapter by replacing the extension tube sidearm with a Luer-activated valve, noted the company in the press release.