FDA Clears EnsiteVascular Femoral Compression Device

EAG, March 11, 2020

New Vascular Compression Device simulates manual compression, removes variability, and leaves nothing behind

(OLATHE, KANSAS, Mar. 31, 2020) EnsiteVascular announced that its SiteSeal Femoral Compression Device received market approval by the Food and Drug Administration (FDA) as a vascular closure device. This system has been safely and successfully used to establish hemostasis post-endovascular procedures without using manual compression, and also it removes the associated variables and risk of unnecessary complications.

SiteSeal is a next generation vascular closure device that simulates manual compression while removing associated variability. They absolutely leave nothing behind. Nothing within the vessel, vessel wall or any surrounding soft tissues. There is minimal patient discomfort, a minimal risk of complications and lower costs.

“SiteSeal is unlike any VCD available on the market. Our simple-to-use, atraumatic, single device can ambulate patients in approximately one hour after diagnostic procedures and approximately two hours after interventional procedures unless modified by physician. Patients can lie more comfortably with their heads at a 30-degree angle, and allows free leg movement,” said Tom Reidy, EnsiteVascular’s president and CEO, “SiteSeal closes the artery without leaving a foreign body behind or a vascular alteration of the femoral artery. It is designed for use on patients of all shapes and sizes, including those who are morbidly obese or have calcification.”

Since post-endovascular procedure hemostasis from manual compression takes up a third of a professional’s time and other types of VCDs introduce significant variability, SiteSeal represents a new approach to vascular closure.

Reidy explains, “SiteSeal’s performance has been extraordinary. At one point, 45 EVAR and 23 Impella procedures had been completed using SiteSeal without any hematoma formation at discharge and at 24-hour, 7-day and 30-day follow up appointments. This is remarkable and requires just a Z stitch, yet solves a number of challenges, such as immediate re-access; risks of vessel wall injury, infection, embolization; patient size, anti-coagulation and calcification limits; leaving behind a foreign body or vascular alteration of the femoral artery; not to mention patient discomfort.”

“Since beginning my practice in 1968, I have been actively involved in cutting edge technology. Over the years, I’ve assisted in designing, developing and implementing many medical devices and interventional procedures. I look forward to increasing awareness about our new technologies among endovascular physicians who are frustrated with inherent complications and associated outcomes with existing VCD’s,” said Dr. Rex Teeslink, a vascular and interventional radiologist and EnsiteVascular’s co-inventor, co-founder and medical director.

This latest FDA clearance is in addition to the prior clearing of Ensite Vascular’s SiteSeal SV, a single VCD that establishes small-vessel hemostasis with a minimal complication rate.

 

About EnsiteVascular

EnsiteVascular was founded to improve vascular closure outcomes for physicians and their increasing number of patients with peripheral arterial disease and structural heart diseases. The company’s unique technologies replace the need for manual compression, as well as removing the variables and complication risks associated with other VCDs while leaving nothing behind to further assist the endovascular physicians’ procedures, and improve patient outcomes. Visit http://www.ensitevascular.com for more information.

 

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