xDot Medical Inc Announces Successful First in Human Study for xCinch Access Management System™
MAPLE GROVE, MN, USA, February 12, 2024 /EINPresswire.com/ -- xDot Medical Inc has announced the successful first-in-human use of its xCinch Access Management System™ for vascular closure for large bore arterial and venous therapies. The procedures were performed at Sanatorio Italiano, Asuncion, Paraguay with Dr. Adrian Ebner. Dr. Susheel Kodali, Director of the Structural Heart and Valve Center at New York Presbyterian / Columbia University Medical Center, and Dr. Vivian Ng, Director of Clinical Services in the Structural Heart and Valve Center at New York Presbyterian / Columbia University Medical Center performed the access and closure with the xCinch device. Five arterial and three venous closures were successfully performed with excellent clinical, hemodynamic, and angiographic results. In all cases, instantaneous hemostasis was achieved.
Large bore catheter-based therapies using femoral arterial or venous access comprise one of the fastest growing medical device segments and are estimated to serve more than 3 million patients annually by 2030. The current vascular closure solutions are inadequate and have unacceptably high failure rates. The xCinch Access Management System™ has been designed to reduce failure rates, especially in calcified vessels. Its patented dynamic cinching mechanism provides automated instantaneous closure. It maintains guidewire access throughout the procedure and does not require manual compression upon large bore sheath removal.
“The approach is based on proven suture-based closure with an extravascular implant. The novel co-axial cinching mechanism performed exceedingly well in both arterial and venous closure. I was very impressed by the instantaneous hemostasis achieved in all the cases,” commented Dr. Kodali.
“The xCinch device was very easy to use. Its deployment technique can be readily learnt and will be familiar to physicians performing large bore access procedures. I can see this device becoming routinely adopted into cardiac and peripheral procedures,” commented Dr. Ng.
Steven F Bolling, MD, a cardiac surgeon and xDot Board member attended the cases and remarked, “xCinch truly replicates the surgical gold standard of vascular closure. It also adapts and automates the surgical purse-string approach to provide a very effective instantaneous closure.”
“This achievement is a significant milestone in our journey to bring this novel device to physicians and patients and reduce access site related bleeding complications in catheter-based therapies. We are excited with the outcomes in this preliminary clinical study that demonstrates the benefits of our approach,” said Aashiish Agnihotri, PhD, the CEO of xDot Medical.
Caution: The xCinch Access Management System™ is an investigational device and not available for sale.
About xDot Medical
xDot Medical is a privately held early-stage medical device company developing xCinch Access Management System™, a novel vascular closure solution for femoral arterial and venous catheter-based therapies. To learn more about xDot Medical, please visit: www.xdotmedical.com
Large bore catheter-based therapies using femoral arterial or venous access comprise one of the fastest growing medical device segments and are estimated to serve more than 3 million patients annually by 2030. The current vascular closure solutions are inadequate and have unacceptably high failure rates. The xCinch Access Management System™ has been designed to reduce failure rates, especially in calcified vessels. Its patented dynamic cinching mechanism provides automated instantaneous closure. It maintains guidewire access throughout the procedure and does not require manual compression upon large bore sheath removal.
“The approach is based on proven suture-based closure with an extravascular implant. The novel co-axial cinching mechanism performed exceedingly well in both arterial and venous closure. I was very impressed by the instantaneous hemostasis achieved in all the cases,” commented Dr. Kodali.
“The xCinch device was very easy to use. Its deployment technique can be readily learnt and will be familiar to physicians performing large bore access procedures. I can see this device becoming routinely adopted into cardiac and peripheral procedures,” commented Dr. Ng.
Steven F Bolling, MD, a cardiac surgeon and xDot Board member attended the cases and remarked, “xCinch truly replicates the surgical gold standard of vascular closure. It also adapts and automates the surgical purse-string approach to provide a very effective instantaneous closure.”
“This achievement is a significant milestone in our journey to bring this novel device to physicians and patients and reduce access site related bleeding complications in catheter-based therapies. We are excited with the outcomes in this preliminary clinical study that demonstrates the benefits of our approach,” said Aashiish Agnihotri, PhD, the CEO of xDot Medical.
Caution: The xCinch Access Management System™ is an investigational device and not available for sale.
About xDot Medical
xDot Medical is a privately held early-stage medical device company developing xCinch Access Management System™, a novel vascular closure solution for femoral arterial and venous catheter-based therapies. To learn more about xDot Medical, please visit: www.xdotmedical.com
Aashiish Agnihotri
xDot Medical Inc
aashiish.agnihotri@xdotmedical.com
