Serranator® has achieved regulatory approvals from both FDA and European Medicines Agency, paving way for successful commercialization
WAYNE, Pa.–(BUSINESS WIRE)—Cagent Vascular, a developer of next-generation technology for vessel dilatation in cardiovascular disease interventions, announces the issuance of its CE Marking for the Serranator ® PTA Serration Balloon Catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator® is one of a family of peripheral artery disease (PAD) technologies which incorporates proprietary Serration Technology to an angioplasty balloon.
The Serranator® has four embedded metal strips on an angioplasty balloon designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion. Material that is serrated is more responsive to directed energy. In angioplasty, the serrated lines are more responsive to the balloon’s energy, thus achieving lumen expansion in a controlled and predictable way.
“Angioplasty is simple and inexpensive but doesn’t work very well. A distinct and unique advantage of the Serranator® is that it capitalizes on the simplicity and familiarity of angioplasty while introducing a new and more effective method of vessel expansion,” states Chief Medical Officer and co-founder Dr. Peter Schneider.
“Achieving CE Marking is an important milestone as we build upon physician enthusiasm for our device and finalize plans for successful commercialization,” says CEO Carol Burns. “In addition to the Serranator® Alto device for use in treating diseased SFA and popliteal arteries, we are developing theSerranator® Bass for the infrapopliteal arteries. Both devices are expected to be part of the commercial product offering in 2018. We believe both devices have the potential to be best-in-class devices.”
At this years’ TCT Conference, Dr. William Gray presented the PRELUDE study results. The study (n=25) assessed the Serranator® Alto device in the superficial femoral and popliteal arteries. The subject population included 28% with a Chronic Total Occlusion (CTO). In 56% there was moderate to severe calcification as determined by the Yale Angiographic Core Laboratory. The acute results showed 100% device 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%. There were no flow limiting dissections nor major adverse events. A subset of subjects (n=10) had Optical Coherence Tomography (OCT) or Intravascular Ultrasound (IVUS) imaging performed after Serranator® use. A serration effect was shown in all 10 subjects. “The study showed safe and effective treatment in critical femoro-popliteal lesions with a low bailout stent rate and low final residual stenosis,” says Dr. Gray.
Cagent Vascular received FDA Clearance for its first product, Serranator ® Alto, early this year. It 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.