Transit Scientific’s XO Constrain 2.2 F Angioplasty Platform Cleared by FDA

June 26, 2024—Transit Scientific announced that its XO Constrain 2.2 F angioplasty platform received FDA clearance to modify calcified plaque and fibrous lesions in the peripheral vasculature. The 510(k) clearance includes the XO Constrain 10-, 15-, and 20-mm configurations. All three variations are offered with a 145-cm working length.

According to the company, the XO Constrain catheter is a low profile balloon dilation scoring and constraining catheter that works with compliant and semicompliant off-the-shelf percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) balloons to expand the constraining structure. It is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels.

Transit Scientific stated that the XO Constrain platform is compatible with a broad range of off-the-shelf PTA and PTCA balloons ranging in diameter from 1.5 to 4 mm and lengths from 6 to 20 mm.

The XO Constrain facilitates dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is not for use in the coronary or neurovasculature, advised the company.

“The XO technology has shown effectiveness modifying, cracking, and dilating intimal and medial calcium using low pressures,” commented Richard Saxon, MD, in the company’s press release. “The new XO Constrain device brings added flexibility and a low profile, making it a good option for peripheral artery disease and critical limb ischemia disease below the knee and potentially below the ankle.” Dr. Saxon is with Tri-City Medical in San Diego, California.

Joseph Steele, MD, added, “Often physicians pull PTCA balloons when treating the very small vessels in the distal peripheral vasculature and pedal vessels. The ability of XO Constrain to work with off-the-shelf PTCA balloons to facilitate controlled, concentric dilatation of stenosis in these small vessels provides a unique and exciting option for patients in need.”