BACKGROUND
There are more than 150,000 lower extremity amputations in the U.S. each year. Most are due to a circulation disorder known as “peripheral arterial disease” (“PAD”).
Catheter-based interventional procedures for below the knee (“BTK”) arteries can be limb-saving for patients at risk of amputation due to PAD.
THE PROBLEM
But catheter-based interventional procedures below the knee are complex, typically requiring numerous exchanges of conventional equipment during a single procedure.
That can make those procedures lengthy to perform. In addition they use x-ray contrast which can damage kidney function. They are done using fluoroscopy, and can entail high doses of radiation.
THE SOLUTION
A multifunctional catheter that serves as a crossing catheter, diagnostic angiography catheter, and angioplasty balloon catheter can streamline below knee interventional procedures by allowing injection of fluids or pressure measurements on the fly, at any time, and reduce equipment, radiation, and contrast needs.
READ MOREFinesse BTK MulticathTM
Until now, all peripheral angioplasty balloon catheters were repurposed coronary angioplasty devices. When used in coronary arteries, the guide catheter provides a convenient means for injection of contrast, vasodilators, or other medications to an artery of interest. However, monofunctional balloon catheters are less effective in peripheral vascular procedures, where the angioplasty site may be located far from the introducer sheath.
Summa pioneered “multicaths”, multifunctional catheters designed for peripheral arterial angioplasty. Featuring ultra-low tip profiles and high performance angioplasty balloons, multicaths serve as diagnostic, crossing, and angioplasty balloon catheters all in one.
Multicaths are injection-ready at all times, even while over the wire, and make some catheter exchanges unnecessary and eliminate the need for long sheaths or specialized crossing catheters. Multicaths are a paradigm shift, a new approach to below knee revascularization.
Human Factors
Ergonomic biodesign enhances the user experience and reduces operator strain.
Combining multiple functions in a single device can reduce the need for cumbersome catheter exchanges and make procedures easier to perform. Fewer exchanges can mean less lost guidewire accesses.
Patient Access
Making procedures easier to perform has the potential to improve both outcomes and patient access to care.
Improving access is important for an underserved patient population, and can increase the number who undergo attempts at catheter-based arterial revascularization before undergoing amputation.
Procedure Safety
Half of patients undergoing BTK revascularization have diabetes or chronic kidney disease and are at risk of contrast-induced nephropathy (CIN).
Injection of contrast close to the site can spare contrast and may reduce the incidence of CIN in at-risk patients.
The image of BTK arteries above was obtained with just 1 ml equivalent of contrast (300 mg/ml) injected through the Finesse multicatheter.
Key Opinion Leader Testimonials
Here’s what clinical thought leaders say about Finesse:
“Limb salvage angioplasty procedures are complex. Reducing catheter exchanges is essential”
Rob Lookstein, M.D.
“In our busy CLI practice, this will definitely be an important tool for us”
John Rundback, M.D.
“Contrast appears distally almost immediately–we’re using less contrast and less radiation’”
Kevin Herman, M.D.
Have a question?
HEAR FROM USLatest News
Check back for exciting news!!
FDA Clears Finesse Injectable “Gen 2”
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[…]
Read more
