Cagent Vascular’s Serrantor Alto PTA Serration Balloon Catheter Receives CE Mark
November 21, 2017—Cagent Vascular announced that its Serranator Alto PTA serration balloon catheter has received CE Mark approval.
The Serranator Alto, which received FDA approval earlier this year, is indicated for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
According to the company, the Serranator Alto has four metal strips embedded on an angioplasty balloon designed to create multiple longitudinal lines of interrupted microserrations to aid artery expansion. The concept behind the platform includes that serrated material is more responsive to directed energy, and in angioplasty, the serrated lines are more responsive to the balloon’s energy, thus achieving lumen expansion in a controlled and predictable way, advised Cagent Vascular.
In the announcement, Cagent Vascular noted that William Gray, MD, had presented the PRELUDE study results at the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium that was held October 30 to November 2 in Denver, Colorado. The study assessed the Serrantor Alto device in the superficial femoral and popliteal arteries in 25 patients. Results included 100% technical success and improvement in lumen gain from an average diameter stenosis of 88% to 23% after Serranator use. The bailout stent rate was 4%. No flow limiting dissections or major adverse events were reported, noted Cagent Vascular.
“The study showed safe and effective treatment in critical femoropopliteal lesions with a low bailout stent rate and low final residual stenosis,” commented Dr. Gray in the company’s announcement.