December 16, 2015 — Scientists at CBSET have presented preclinical evidence that the Manta Large Bore Vascular Closure Device (VCD) from Essential Medical successfully closed large bore arterial access without complication. The study, presented at the Innovations in Cardiovascular Medicine (ICI) meeting in Tel Aviv, Israel, also showed the Manta VCD 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). These complications cause a long time to achieve hemostasis and extend OR time, requiring the need for a vascular surgeon in the cath lab and 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.”
In July 2015, Essential Medical announced that it had successfully commenced EU clinical studies using its Manta Large Bore VCD, 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 more information: www.cbset.org