“Vascular access complications are a significant source of morbidity, especially for interventions such as TAVR that require large bore cannulation,” said Haim Danenberg, M.D., CBSET’s chief scientific advisor. “CBSET’s study demonstrates that MANTA is a safe and reliable large-bore percutaneous closure device.”
LEXINGTON, Mass., Dec. 10, 2015 — Scientists at CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, will present preclinical evidence at next week’s “Innovations in Cardiovascular Interventions” (ICI) meeting in Tel Aviv, Israel, demonstrating that the MANTA Large Bore Vascular Closure Device (VCD) from Essential Medical (Malvern, Penn.) “successfully closed large bore arterial access without complication and exhibited favorable healing characteristics as assessed by serial histomorphology.”
Vascular access site complications are a significant source of morbidity following percutaneous catheterization, especially for interventions requiring large bore cannulation, such as transcatheter aortic valve replacement (TAVR), causing a long time to achieve hemostasis and extending OR time, requiring the need for a vascular surgeon in the cath lab, delaying patient ambulation, causing a high rate of complications and high total cost of care.
“The benefit of a vascular closure device over the standard of manual compression is most pronounced for large bore access and higher baseline-risk patients. The fact that the MANTA VCD uses a collagen implant secured by an intraluminal anchor makes it especially suited for large bore cannulation,” said Haim Danenberg, M.D., Chief Scientific Advisor, CBSET, and Head of the Cardiovascular Research Center and Director of Interventional Cardiology at the Heart Institute of Hadassah Hebrew University Medical Center, Jerusalem.
“MANTA is designed to close a large arteriotomy left by vascular access sheaths in high-pressure vessels in less than 60 seconds, providing immediate hemostasis in order to reduce complications associated with large bore closure,” said study director Lynn Bailey, Director of Interventional Services, CBSET. “In our study, the MANTA VCD rapidly achieved patent hemostasis, and there was no evidence of vascular occlusion or other complications on long-term follow-up,” added lead author, Kenta Nakamura, M.D., Fellow in Cardiovascular Disease at Massachusetts General Hospital; and, Research Fellow in Applied Sciences, CBSET. “The device was well-tolerated with favorable cellular response and tissue healing on histopathology.”
“With CBSET’s help, Essential Medical has been able to cost-effectively validate its disruptive technology by developing and employing the most appropriate animal models. We are excited to be able to couple our outstanding clinical science with outstanding preclinical science,” said Gary Roubin, M.D., Ph.D., Chief Medical Officer, Essential Medical (www.essmedclosure.com).
In July 2015, Essential Medical announced that it had successfully commenced EU clinical studies using its MANTA Large Bore Vascular Closure device, designed to seal both 14F and 18F large bore femoral punctures. Cases were conducted by Nicholas Van Mieghem, M.D., Ph.D., Medical Director of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, who commented that MANTA, “is a revolutionary device that will transform how we close cases.”
For a copy of the CBSET ICI 2015 presentation, please visit CBSET’s Booth #50 at ICI 2015 or contact Dr. Erica Smith, Director of Business Development at CBSET: +1-781-296-5319, esmith@cbset.com
About CBSET
CBSET Inc. — 500 Shire Way, Lexington, MA 02421 — is the preclinical research leader in critically important therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products.