OLATHE, Kan., Feb. 10, 2021 /PRNewswire-PRWeb/ -- EnsiteVascular, the medical device company behind the SiteSeal vascular closure device (VCD), welcomes renowned cardiology experts: Drs. Matthew Earnest, George Christy, Pradeep Nair, and Craig Walker to its inaugural Medical Advisory Board (MAB).
The formation of the MAB comes on the heels of SiteSeal's market approval by the Food and Drug Administration (FDA) as a VCD with impending studies to be conducted in Austin, TX for SiteSeal's use in electrophysiology (EP) procedures. SiteSeal offers physicians the unique ability to close multiple sheaths sites in a single vessel with a single device, while leaving nothing behind post-use. The new MAB provides EnsiteVascular's leadership with an external medical perspective and high-level insight regarding the company's VCD usage in all endovascular procedures, both arterial and venous, large and small bore, as well as clinical studies and future follow-on indications.
"Creating our Medical Advisory Board is an important milestone for EnsiteVascular. It's a privilege to have the caliber of cardiologists we have as initial MAB members," states Tom Reidy, EnsiteVascular's president and CEO, "Collectively, their vast experience, relationships, participation in other device studies, and standing in their specialty will be invaluable as we continue to advance toward making SiteSeal the standard of care for endovascular procedures, as well as exploring its performance and value in other applications, such as EP and Structural Heart."
SiteSeal, a next-generation VCD, has been used safely and successfully to establish hemostasis post-endovascular procedures without the need for manual compression, while also mitigating associated variables and risk of unnecessary complications. SiteSeal leaves nothing behind within the vessel, vessel wall or surrounding soft tissues. Additional benefits include minimal patient discomfort, and minimal risk of complications. This VCD allows ambulation of patients approximately one hour after diagnostic procedures and approximately two hours after interventional procedures. Patients of all shapes and sizes, including those who are morbidly obese or have calcification, can lie more comfortably with their heads at a 30-degree elevation immediately after use and freely move their legs.
"SiteSeal's performance in endovascular procedures is extraordinary," says Reidy. "Our VCD is a unique approach utilizing a Z stich which allows SiteSeal to elevate the soft tissues around the vessel, and close the arterial or venous access sites in a linear fashion, optimize platelet aggregate formation and support hemostasis. In some venous endovascular procedures, such as EP, there is a need for a single device to close multiple venous sheaths in a single vessel while leaving nothing behind. Our MAB's guidance will be invaluable as we move forward in EP, having successfully completed animal trials, as EP procedures are a particularly high-growth area. If SiteSeal performs as well in EP as it does in other endovascular techniques, EP procedures could be performed on an outpatient basis with reliable closure."
The FDA cleared EnsiteVascular's SiteSeal femoral compression device in 2020. In addition, the FDA cleared the SiteSeal SV(small vessel) device for the closure of radial artery access in 2020 as well. Clinical studies have been completed for a second indication for the SiteSeal SV, the closure of brachial artery access. FDA approval pending.
EnsiteVascular was founded to improve vascular closure outcomes for physicians and their increasing number of patients for all their endovascular procedures, both arterial and venous, and uniquely, leaves nothing behind. Visit http://www.ensitevascular.com for more information.
Tom Reidy, EnsiteVascular, 1-816-260-8476, [email protected]