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Teleflex Announces First Patient Enrollment in ACCESS-MANTA Registry
Registry Intends to Examine Contemporary On-Label Use of the MANTA Vascular Closure Device Including Appropriate Patient Selection and Proper Vascular Access
Registry Intends to Examine Contemporary On-Label Use of the MANTA Vascular Closure Device Including Appropriate Patient Selection and Proper Vascular Access
WAYNE, Pa. -- Teleflex Incorporated announced the first patient enrollment in a clinical registry that is intended to examine and collect data on outcomes of contemporary on-label use of the MANTA™ Vascular Closure Device (VCD) in standard of care transcatheter aortic valve replacement (TAVR) procedures. The registry will include appropriate patient selection and proper vascular access.
Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA™ Registry is an international, multicenter, prospective, observational, single-arm clinical registry. It will employ the primary objectives of safety, defined by VCD large bore access site-related Valve Academic Research Consortium-3 (VARC-3) major and minor vascular complications within 30 days of the TAVR procedure, and effectiveness, defined by time to hemostasis or the elapsed time between MANTA™ Device deployment and the first observed and confirmed arterial hemostasis. The study will also evaluate technical success, treatment success, ambulation success, discharge readiness, and procedure time.
“Large bore access site complications are recognized as morbid,1 driving increased costs and prolonged length-of-stay,2” said Teleflex Interventional Medical Director, Christopher Buller, MD. "That is why percutaneous cardiac and peripheral procedures, such as TAVR, that are performed through large bore arteriotomies, need dedicated closure technology that is safe and effective as well as procedurally efficient.”
“The MANTA™ Device demonstrated those attributes in the pivotal SAFE MANTA IDE Clinical Trial,3” Dr. Buller added. “However, TAVR practice has since evolved to embrace routine access site imaging, awake procedures, somewhat smaller delivery systems and sheaths, lower-risk patients, and considerably higher per-operator experience. The ACCESS-MANTA™ Registry will allow us to understand the degree to which these changes, coupled with a dedicated device that is optimally deployed, may improve large bore outcomes.”
The study chair is George Dangas, MD, PhD, Professor of Medicine (Cardiology), and Surgery, and the Director of Cardiovascular Innovation at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai. The principal investigators of the study include Sahil Khera, MD, Interventional Director of the Structural Heart Program at The Mount Sinai Hospital, and Danny Dvir, MD, Director of Interventional Cardiology at Shaare Zedek Hospital Center, Jersualem.
“We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator. “The study focuses on on-label use of the MANTA™ Device, appropriate patient selection using pre-TAVR CT imaging, and proper vascular access, all of which reflect the standard practice at our world class, high-volume TAVR center. We look forward to this contribution to the advancement of large bore access and closure.”
About the MANTA™ Vascular Closure Device
The MANTA™ Vascular Closure Device is the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.4 Since the first implantation in 2014, receiving its CE mark in 2016, and FDA approval in 2019, the MANTA™ Device has been well studied in over 10,000 patients and in 70+ publications. Over 150,000 units have been sold globally.4
Available in 14 and 18 Fr. sizes, the MANTA™ Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20 Fr. devices or sheaths (12-25 Fr. O.D.) in endovascular catheterization procedures. The technology creates an alternative to cut down and suture-mediated closure for large bore procedures and has proved useful in TAVI/TAVR, EVAR/PEVAR/TEVAR, and BAV.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, LMA®, Pilling®, QuikClot®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose.
References
1Piccolo R, Pilgrim T, Franzone A, Valgimigli M, Haynes A, Asami M, Lanz J, Räber L, Praz F, Langhammer B, et al. Frequency, timing, and impact of access-site and non-access-site bleeding on mortality among patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2017; 10:1436–1446. doi: 10.1016/j.jcin.2017.04.034.
2Arbel Y, Zivkovic N, Mehta D, Radhakrishnan S, Fremes SE, Rezaei E, Cheema AN, Al-Nasser S, Finkelstein A, Wijeysundera HC. Factors associated with length of stay following trans-catheter aortic valve replacement - a multicenter study. BMC Cardiovasc Disord. 2017; 17:137. doi: 10.1186/s12872-017-0573-7.
3 The SAFE MANTA IDE Clinical Trial. Study sponsored by Teleflex Incorporated or its affiliates.
4 Data on file at Teleflex.
CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.
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