Cagent Vascular’s Serranator Device in BTK Arteries Compared to POBA in RECOIL Study

July 11, 2023—Cagent Vascular, a Pennsylvania-based developer of serration technology for vessel dilatation in endovascular interventions, announced the results of its below-the-knee (BTK) Serranator RECOIL study. The results demonstrated that treatment of BTK lesions using the company’s Serranator percutaneous transluminal angioplasty serration balloon catheter exhibited 49% less average recoil compared to plain old balloon angioplasty (POBA).

According to the company, the core-lab adjudicated RECOIL analysis is evaluating vessel recoil in lesions of the BTK arteries treated with the Serranator versus POBA. The Serranator device embeds serration technology into a semicompliant balloon for treating peripheral artery disease. It is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion. It has received FDA clearance and CE Mark approval.

Cagent advised that the study’s 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.

The RECOIL study is led by Coprincipal Investigators Stefan Stahlhoff, MD, of the Arnsberg Clinic in Arnsberg, Germany, and Venita Chandra, MD, of Stanford University in Stanford, California.

The company reported that 36 patients with 39 lesions up to 22 cm in length were matched 1:1 for treatment with either the Serranator or POBA.

In each procedure the lumen diameter was measured immediately post angioplasty and then again at 15 minutes postinflation. The degree of vessel recoil was assessed angiographically and then core-lab adjudicated.

The data showed a mean percent recoil of 6% in the Serranator group versus 55% in the POBA group, which represents a 49% reduction in recoil using serration angioplasty. Cagent noted that 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,” commented study investigator Michael Lichtenberg, MD, in the company’s press release. “The 49% difference demonstrated in the RECOIL study between Serranator and POBA is statistically significant and, in my view, also clinically relevant.”

Dr. Lichtenberg continued, “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.”

Also, in Cagent’s press release, Dr. Chandra commented, “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. Our chronic limb-threatening ischemia patient population is particularly vulnerable and at greater risk of limb loss and the associated increase in mortality that accompanies amputation.”

Dr. Chandra stated further, “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.”