New Vascular Compression Device simulates manual compression, removes variability and leaves nothing behind
OLATHE, Kan., June 7, 2022 /PRNewswire-PRWeb/ -- EnsiteVascular announced that its SiteSeal Femoral Compression Device received patent approval in the European Union (EU) as a vascular closure device (VCD). SiteSeal is a next-generation VCD that simulates manual compression while significantly reducing patient and user variability and unnecessary complications.
The device is targeting fast-growing and unmet demand for large-bore closure systems in TAVR/EVAR procedures. Uniquely, the device can be used as a standalone in these procedures to close arteriotomy sites whereas leading competitors require multiple applications and/or adjunctive manual compression. Taken together, SiteSeal is positioned for rapid market uptake due to safe and reliable closure at reduced costs. The patent allowance in the EU follows the company's FDA approval in the U.S. for their small bore/peripheral closure system, SiteSeal SV.
"We are excited to pursue the European marketplace for both our radial and brachial devices, so we can move forward in the CE marking process. SiteSeal is unlike any VCD available on the market, and yet it's the one that physicians have been asking for. The simple-to-use, atraumatic, single device can ambulate patients in approximately one hour after diagnostic procedures and approximately two hours after interventional procedures. Patients can lie more comfortably with their heads at a 30-degree angle and are allowed free leg movement. 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," says Tom Reidy, EnsiteVascular's CEO and president. "Moreover, SiteSeal closes the artery without leaving a foreign body behind or vascular alteration to the femoral artery."
SiteSeal represents a new approach to vascular closure as post-endovascular procedure hemostasis from manual compression takes up a third of a professional's time and other types of VCDs introduce significant variability. Dr. Rex Teeslink, a vascular and interventional radiologist and EnsiteVascular's co-inventor and medical director comments, "Since beginning my practice, I have been actively involved in cutting edge medical 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 around the world who are frustrated with inherent complications and limitations with existing VCDs."
About EnsiteVascular
EnsiteVascular is a clinical stage medical technology company that 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.
Media Contact
Tom Reidy, Ensite Vascular, 816-260-8476, [email protected]
SOURCE Ensite Vascular
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