Study: Less Recoil Associated With Cagent Vascular’s Angioplasty Balloon

Cagent Vascular is sharing results of its Below-the-Knee (BTK) RECOIL study, a first-of-its-kind analysis that evaluated vessel recoil in lesions treated with Serranator.

Lesions treated with Serration angioplasty exhibited 49% less average recoil than Plain Old Balloon Angioplasty (POBA), according to study results. Stefan Stahlhoff, M.D. (Arnsberg Clinic, Arnsberg, Germany) and Dr. Venita Chandra (Stanford University, Stanford, Calif.) led the RECOIL study as co-principal investigators. “We’re very encouraged and humbled by the results of this study. We believe Serration Angioplasty can move the needle for this critical community of patients,” Cagent Vascular President/CEO Carol A. Burns stated. “Prior studies have shown the positive impact this technology can have towards achieving a greater lumen with fewer complications, and ultimately providing more blood flow to support wound healing. We look forward to understanding how this technology may enhance longer term patient outcomes.”
 
The Serranator PTA Serration Balloon Catheter (Serranator) is the first and only angioplasty balloon cleared by American and European regulators that embeds serration technology into a semi-compliant balloon for treating peripheral artery disease (PAD). The device is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
 
Thirty-six subjects with 39 lesions in up to 22cm in length were matched one-to-one using either the Serranator or POBA. The study objectives were to assess the ability to define and measure post treatment recoil in infrapopliteal arteries and to show preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection. In each procedure the lumen diameter was measured immediately post angioplasty and then again at 15 minutes post inflation. The degree of vessel recoil was assessed angiographically and then corelab adjudicated. These data showed a mean percent recoil of only 6% in the Serranator group versus 55% in the POBA group, representing a 49% reduction in recoil using serration angioplasty. Notably, there were no flow limiting dissections in either lesion treatment group, suggesting that optimal inflation technique impacts dissection rates, but not recoil rates.
 
“The recoil phenomenon is well understood as one of the greatest headwinds to successful BTK treatment and ultimately wound healing,” said Dr. Michael Lichtenberg, who participated in the study. “The 49% difference demonstrated in the RECOIL study between Serranator® and POBA is statistically significant and in my view also clinically relevant. Wound healing requires a durable lumen to support brisk blood flow, and 55% recoil for POBA treated lesions is a signal that our current 40-year POBA standard therapy is inadequate. I believe this study is a further step in demonstrating Serration Angioplasty as a definitive treatment for BTK lesions.”
 
“We know that BTK interventions are highly susceptible to vessel recoil, however the impact of recoil on residual stenosis at 15-minutes post procedure makes the true severity of this challenge clear,” Chandra added. “Our CLTI patient population is particularly vulnerable and at greater risk of limb loss and the associated increase in mortality that accompanies amputation. While this initial RECOIL study did not follow patient outcomes, in the future we intend to evaluate how impactful Serration Angioplasty’s recoil improvement is to healing BTK wounds and savings limbs. The results from this comparative RECOIL study are indicative that Serration Angioplasty may be the tool that finally addresses this longstanding challenge with POBA.”

Cagent Vascular has developed the first and only serration balloon technology to treat atherosclerotic disease. It is the second cardiovascular company formed by co-founders Burns; vascular surgeon Peter Schneider, M.D., (chief medical officer); and Robert Giasolli, chief technology officer. The trio previously co-founded Intact Vascular.