Summa’s Finesse Injectable Balloon Catheter Introduced for BTK Angioplasty

January 17, 2024—Summa Therapeutics, LLC announced that the company’s Finesse Injectable balloon catheter platform was used in first-in-human injectable angioplasty procedures for patients with below-the-knee (BTK) peripheral artery disease (PAD).

The company stated that the Summa Finesse Injectable balloon catheter is a hybrid diagnostic and therapeutic device developed to facilitate treatment of patients at risk of limb loss caused by BTK PAD. The multifunctional catheter serves as a crossing catheter, diagnostic angiography catheter, and angioplasty catheter to reduce equipment and contrast needs.

The company recently announced FDA clearance of the Finesse line of injectable balloon catheters for percutaneous transluminal angioplasty in the treatment of PAD.

The Finesse devices are cleared for use in iliac, femoral, popliteal, infrapopliteal, renal arteries, and arteriovenous dialysis access. The Finesse Injectable is the first hybrid catheter launched in its planned line of interventional radiology devices, noted the company.

According to the company, operators reported that the Summa Finesse Injectable catheter allowed for decreased use of x-ray contrast, with 100% of procedures requiring less contrast than typically used with conventional devices. In the calf, ultra-low contrast angiograms were obtained with as little as 1 mL equivalent of contrast. Additionally, it was noted that in many cases with the Summa Finesse catheter functioning as a crossing catheter, microcatheters were not needed to cross arterial obstructions.

The first procedures were performed by Rahul Patel, MD, and Robert Lookstein, MD, at The Mount Sinai Hospital in New York, New York, and by John Rundback, MD, and Kevin Herman, MD, at Advanced Vascular and Interventional Services, an office-base laboratory in West Orange, New Jersey.

“Summa’s system makes BTK angioplasty cases easier compared to a conventional setup,” commented Dr. Herman in the company’s press release. “I start with Finesse and use it to perform angiography, cross lesions, and do serial angioplasties of multiple arterial segments in the calf—all with the same catheter. It’s a better designed system for BTK angioplasty.”

In discussing his experience of the device with Endovascular Today, Dr. Rundback observed, “I was very impressed with our first two commercial cases with this device. The Summa balloon platform provided a distinct clinical advantage when treating infrapopliteal arterial disease, allowing immediate angiography after PTA through the catheters injection lumen thereby facilitating case flow, reducing exchanges, and eliminating the need to remove the wire to obtain images. In our busy critical limb ischemia practice, this will definitely become an important tool for us to improve our patient care.”