Expanded Multifunctional Angioplasty Catheter Product Line for BTK Procedures
CAMBRIDGE, Massachusetts, July 17, 2024— Summa Therapeutics, a specialty angioplasty balloon medical device company, announced today that “Gen 2” of Summa’s revolutionary Finesse InjectableTM angioplasty balloon catheters has been cleared by the FDA for PTA treatment of peripheral artery disease including, among others, infra-popliteal (“below-the-knee”) arteries.
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.
The revolutionary Finesse InjectableTM angioplasty balloon catheter was designed to facilitate increasingly complex below-the-knee angioplasty procedures for patients with critical limb-threatening ischemia (CLTI), a risk factor for leg amputation, and is the first injectable angioplasty balloon catheter designed to treat small arteries in the calf. The combination of a crossing catheter, diagnostic catheter, and angioplasty balloon catheter in one device is expected to reduce catheter exchanges, lower contrast doses, and shorten procedure times, and thereby lead to better patient outcomes and lower costs.
Design improvements in the “Gen 2” version include moving the injection exit holes closer to the angioplasty balloon, adding catheter working lengths of 65 and 100cm, and modifying the injection lumen adapter by replacing the extension tube sidearm with a Luer-activated valve.
“Each of the changes in the Gen 2 redesign was done with the intent of improving the user experience and making revascularization procedures easier,” said Dr. Timothy Murphy, CEO, Summa Therapeutics. “Users told us that in order to optimize visualization in the area of interest they wanted the injection exit ports as close to the balloon as possible. They also wanted 65cm working lengths to facilitate pedal access for BTK [below the knee] revascularization procedures, as well as a 100cm long version for antegrade femoral access for BTK. We also believe the Luer-activated valve fulfills our overall aim of reducing steps and thereby making procedures easier.”
This significant regulatory milestone marks a major achievement for Summa, a leading innovator in the cardiovascular medical device industry. Summa plans to launch the re-designed product line in the fourth quarter of 2024 in the U.S. and in select markets around the world.
For more information about the Finesse angioplasty balloon product line or to inquire about distribution, please visit www.summatherapeutics.com or contact Summa at (877) 267-2685.
About Summa Therapeutics
Summa Therapeutics, LLC, is a leading medical device company specializing in the development and commercialization of innovative solutions for the field of cardiovascular interventional medicine. With a focus on improving patient outcomes, Summa Therapeutics, LLC, is dedicated to delivering cutting-edge medical technologies that address critical unmet needs in cardiovascular care.
Media Contact:
Erica Alejaldre
Point B Partners
954-268-9692
