News

Cagent Vascular Presents Positive Results from the PRELUDE Study at LINC 2018

February 7th, 2018

WAYNE, Pa. – Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular interventions announces positive results from the First-in-Human PRELUDE Study.  Dr. Andrew Holden (Auckland, New Zealand), Principal Investigator, presented 30-day and preliminary 6-month results using the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter at the Leipzig Interventional Course last week.

The PRELUDE Study is a prospective, single-arm, multicenter feasibility study designed to show safety and efficacy of the Serranator® device used in critical lesions in the superficial femoral artery (SFA) and/or popliteal arteries.  The study enrolled 25 subjects at centers in New Zealand and Europe.

“The fascinating part of the trial is that although we had patients, by definition, who were excluded with severe calcification, there was a significant core lab adjudicated group of persons who had lesions with moderate to severe calcification. We could achieve luminal gain to nominal using very low pressures in that subgroup which tells us that this is something quite different from plain balloon angioplasty. Not only being able to dilate these vessels to nominal, which is an achievement on its own, but to do it without a significant incidence of dissection is an achievement. Although the numbers are small this is a really encouraging sign that the serration mechanism of action is a very different way of treating the artery” said Dr. Holden.

The Serranator device has four external metal serrated strips embedded on a semi-compliant balloon. The Serranator’s unique serration technology is designed to create multiple longitudinal lines of interrupted micro-serrations along the arterial surface to aid arterial expansion.  The serrations are responsive to the balloon’s energy, enabling predictable and controlled lumen expansion along the lines. The device received FDA 510(k) clearance and CE Marking in 2017. 

The primary objective was technical feasibility of using the Serranator in critical SFA or popliteal artery lesions.  The secondary objective was the feasibility of using Optical Coherence Tomography (OCT) and or Intravascular Ultrasound (IVUS) in a sub-set (n=10) of subjects to evaluate the presence of serrations.  Eighty percent (n=20) of lesions treated were in the SFA.  Fifty six percent of lesions treated had moderate to severe calcification and 32% were Chronic Total Occlusions (CTO). The pre-diameter stenosis was 87.6% with a final diameter stenosis of 22.7% using just the Serranator device. The mean lumen gain was 3.45 mm in the severe group (n=7) requiring just 8.57 ATM of maximum pressure vs 3.33 mm in the none to moderate group (n=18) using only 7.67 ATM. There were no flow limiting dissections and only 1 bailout stent (4%). All subjects who underwent IVUS or OCT showed a serration effect as analyzed by the core lab. There was 100% patency at 30-days as assessed by Duplex Ultrasound (DUS) and 100% freedom from TLR at 30-days and 6-months.
“In this current era of increasing vessel complexity and economic pricing pressures, treatments need to be effective but not complex. The Serranator is positioned to be the off-the-shelf, “workhorse” solution for SFA and popliteal treatment both for the inpatient and outpatient settings,” says Carol A. Burns, President and CEO.  “We believe these results are a positive signal that the same mechanism of action will work for the treatment of critical limb ischemia where there is an even greater unmet need for a device like ours.”  

Co-founder and Chief Medical Officer, Dr. Peter Schneider commented, “We are impressed with the device performance and especially with its ability to cross very tight lesions.  The catheter’s inherent flexibility and low-profile design, along with its enhanced pushability specific to the BTK device, are highly desired attributes for the challenging treatment of diseased infrapopliteal arteries. We expect to begin the PRELUDE-BTK study later this year.”

About the PRELUDE Study

For more information regarding the PRELUDE Study visit www.clinicaltrials.gov.

Cagent Vascular Announces CE Mark of Serranator®, Next Generation Device for Vessel Dilatation in Peripheral Artery Disease Interventions

Serranator® has achieved regulatory approvals from both FDA and European Medicines Agency, paving way for successful commercialization


November 20th, 2017

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 the Serranator® 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.

CAGENT VASCULAR COMPLETES ENROLLMENT OF PRELUDE STUDY USING SERRANATOR DEVICE

June 5th, 2017

WAYNE, Pa. –(BUSINESS WIRE)–  Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in Human PRELUDE Study. The purpose of this prospective, single-arm, multicenter feasibility study is to show the safety and efficacy of the Serranator® Alto device used in the Superficial Femoral Artery (SFA) and/or Popliteal Artery.

The PRELUDE study is led by Principal Investigator Dr. Andrew Holden (Auckland, New Zealand). Other investigators participating in this study are Drs. Marianne Brodmann (Graz, Austria), Marek Krzanowski (Kraków, Poland) and Przemyslaw Nowakowski (Chrzanów, Poland). The centers enrolled 25 subjects and will participate in a 30-day and 6-month follow-up.

“The PRELUDE Trial evaluating the first in human experience of the Serranator® device has rapidly completed enrollment. Excellent acute results were achieved with 100% device success and a very low bail out stent rate despite a significant number of lesions containing chronic total occlusions and severe calcification. Interestingly, IVUS and OCT confirmed serrations were visible in all imaged patients. We look forward to following these patients as the trial progresses,” said Dr. Holden.

The Serranator® Alto device has four external metal serrated strips embedded on a semi-compliant balloon and is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion. The device received FDA 510(k) clearance earlier this year. The Serranator® Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, and popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. (Not for use in the coronary or neuro-vasculature).

“We are pioneering a new standard of care using Serration Technology with its unique design and mechanism of action. Our next addition to our family of products will be for below-the-knee treatment with the Serranator® Bass, currently in development,” stated Carol A. Burns, President and CEO.

Co-founder, Dr. Peter Schneider commented, “We are impressed with these acute results which showed a reliable increase in lumen gain and arterial expansion. I believe the simple and familiar technique of angioplasty plus the incorporation of Serration Technology in the Serranator® device will continue to prove an effective and valuable tool in treating arterial disease.”

About the PRELUDE Study

For more information regarding the PRELUDE Study visit www.clinicaltrials.gov.

 

CAGENT VASCULAR ANNOUNCES FDA 510(K) CLEARANCE OF NEXT GENERATION DEVICE FOR VESSEL DILATATION IN PERIPHERAL ARTERY DISEASE INTERVENTIONS

February 27th, 2017

WAYNE, Pa.–(BUSINESS WIRE)—Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its lead product, the SerranatorTM Alto PTA Serration Balloon Catheter.   The SerranatorTM is the first of a family of peripheral artery disease (PAD) technologies under development which incorporate proprietary Serration Technology to an angioplasty balloon.

“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today we are treating more complex lesions that require better tools. The SerranatorTM is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion,” says Vascular Surgeon Peter Schneider, MD.

“We believe Serration Technology will prove to be effective in more complex lesions and will evolve into the new standard of care for vessel dilatation. In the future we hope to show clinical benefit as a vessel preparation tool with new technologies such as drug coated balloons,” continued Dr. Schneider.

Cagent Vascular has received FDA Clearance for its first product, SerranatorTM Alto, 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.

“FDA Clearance represents a significant milestone.  Our next step is to initiate a study to assess the clinical safety and efficacy of the technology,” says CEO Carol Burns. “We have also begun the development of the SerranatorTM Bass for treatment of the below-the-knee or infrapopliteal arteries, where new technologies are desperately needed for the treatment of Critical Limb Ischemia. Future applications of interest include Serration Technology for vessel preparation prior to the use of Bioresorbable Scaffolds in coronary arteries.”

About Cagent Vascular

Cagent Vascular is leading the way for next generation technology for vessel dilatation. It is the second cardiovascular company formed by co-founders Carol Burns, President & CEO, Peter Schneider, MD, Vascular Surgeon, Chief Medical Officer and Robert Giasolli, VP of Research and Development. Visit www.cagentvascular.com for more information.

Contact Lauren Pfeiffer +1.610.688.2006 or info@cagentvascular.com

Source: Cagent Vascular

 

 

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150 Strafford Avenue #315
Wayne, PA 19087
610-688-2006
info@cagentvascular.com

The Serranator® is a trademark of Cagent Vascular, LLC

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