FDA Clears Revolutionary Injectable Angioplasty Balloon Product Line For Market Release.
PROVIDENCE, Rhode Island, November 29, 2023— 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 U.S. Food and Drug Administration for the treatment of peripheral artery disease.
Summa’s new Finesse InjectableTM angioplasty balloon catheters are cleared by the FDA for PTA treatment of peripheral artery disease including:
- iliac
- femoral
- popliteal
- infra-popliteal
- renal arteries
- 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 Dr. 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 revolutionize angioplasty procedures, providing physicians with an advanced toolset to treat patients with CLTI.”
The revolutionary new 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. 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.
This significant regulatory milestone marks a major achievement for Summa, a leading innovator in the cardiovascular medical device industry. Summa plans to launch the product line in the 4th quarter of 2023 in the U.S.
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 commercial-stage medical device company specializing in the development and commercialization of innovative solutions for the field of cardiovascular interventional medicine. With a focus on improving lives, Summa Therapeutics, LLC, is dedicated to delivering cutting-edge medical technologies that address critical unmet needs in cardiovascular care.
Media Contact:
Ben Godley
Point B Partners
617-676-7655
ben@pointbpartners.com
