WAYNE, PA — Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announced FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions.
The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). It is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
The company also recently completed enrollment of its PRELUDE-BTK Study, a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of the device. A total of 49 patients were enrolled.
The study is led by Principal Investigator, Dr. Andrew Holden (Auckland, New Zealand). Six centers from Europe and New Zealand are participating in the trial which will include 30-day and 6-month follow up.
“This trial enrolled quickly, which speaks to the enthusiasm for better technology like the Serranator. Treating BTK lesions is a challenge due to the unpredictability we often see with existing balloon therapy such as insufficient lumen gain, vessel dissection and recoil. These arteries are small in diameter, often calcified, with much of the disease located in the distal portion of the leg, making treatment a challenge,” stated Dr. Holden.
The global increase in diabetes, obesity, and sedentary lifestyle is compounding the prevalence and severity of PAD. Furthermore, patients are often underdiagnosed and underserved.
If left untreated, the advanced stages of this disease, referred to as Chronic Limb-Threatening Ischemia (CLTI), can result in severe leg pain, non-healing wounds, limited mobility, amputation and increased mortality. Plain Old Balloon Angioplasty (POBA) remains the most frequently performed procedure, yet this standard therapy often yields unpredictable and undesirable results.
“Our experience with the Serranator in the PRELUDE-BTK Study has been positive. In a standard BTK procedure using a POBA, we often see impaired flow due to recoil. It is impressive to see the lumen gain we get with minimal recoil. Our center’s 3 investigators have all noted similar experiences with the device,” commented Dr. Marianne Brodmann (Graz, Austria).
Carol A. Burns, President and CEO of Cagent Vascular added, “Obtaining FDA clearance and completion of the PRELUDE-BTK trial enrollment were critical milestones for the company’s growth. We are grateful to our investigators for treating these subjects and are encouraged by the positive acute angiographic results.
“These are in line with our previous experience from the PRELUDE, above-the-knee study. We believe Serration Technology is truly differentiating in its ability to achieve lumen expansion and restore blood flow with minimal injury. Our goal is for the Serranator to become the standard of care for balloon based peripheral interventions.”
The Serranator product offering for the infrapopliteal indication includes 2.5, 3.0, 3.5mm balloon diameters and 40, 80 and 120mm balloon lengths. In the coming months, the Company plans to complete manufacturing validations and to expand its clinical experience with US physicians.
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