News | Structural Heart | March 31, 2022

Vivasure Medical Announces First Patient Treated in U.S. Early Feasibility Study Evaluating PerQseal+

Study is the first in the U.S. to evaluate the company’s fully absorbable, patch-based percutaneous closure device for large-bore vessels in transcatheter aortic valve replacement

Vivasure Medical, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the first patient was treated in a U.S. early feasibility study evaluating PerQseal+, the next generation of the company’s PerQseal device.

March 31, 2022 – Vivasure Medical, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the first patient was treated in a U.S. early feasibility study evaluating PerQseal+, the next generation of the company’s PerQseal device. The study is designed to evaluate PerQseal+ in percutaneous transcatheter aortic valve replacement (TAVR) procedures. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial vessel closure.

The patient was treated at Stony Brook University Hospital in Stony Brook, New York by Robert Pyo, M.D., director of interventional cardiology and co-director of structural heart cardiology, Stony Brook Medicine.

“We are pleased to participate in this study of the PerQseal+ vessel closure device, a promising tool intended to advance the standard of care for patients undergoing minimally invasive structural heart procedures,” said William Gray, M.D., system chief, division of cardiovascular disease at Main Line Health, co-director at the Lankenau Heart Institute in Philadelphia and the principal investigator for the study. “This study will allow us to evaluate PerQseal+ for safe, efficient and secure large-bore vessel closure with a novel non-suture mechanism design, which has great potential for effectively managing vascular access without the complications typically associated with large-bore closure.”

Vivasure Medical’s first generation PerQseal device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe. The novel PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state and does not leave the remains of any collagen, metal implants or sutures. The PerQseal+ device has an enhanced bioabsorbable patch designed to address more complex patient anatomies and is currently under clinical evaluation in Europe.

“Despite years of advancement, vascular complications remain the most common event for TAVR procedures, so further innovation is needed. Enrolling the first patient in this study is an important step forward in bringing a new, cutting-edge option for large-bore vessel closure to physicians in the U.S.,” said Andrew Glass, chief executive officer of Vivasure Medical. “We are looking to initiate a pivotal trial in the U.S. later this year to further evaluate our PerQseal technology for safety and efficacy in percutaneous large-bore endovascular procedures, which will support our submission to the FDA.”

Vivasure Medical is also developing PerQseal Blue, which is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). Currently, there are no sutureless options for venous closure following large-bore venous closure procedures.

For more information: www.vivasuremedical.com

Related Content

News | Structural Heart

June 9, 2022 — Abbott announced late-breaking data for MitraClip, the world's first transcatheter edge-to-edge repair ...

Home June 09, 2022
Home
News | Structural Heart

May 25, 2022 — ŌNŌCOR LLC, a leader in endovascular safety technology, today announced it has received 510(k) U.S. Food ...

Home May 25, 2022
Home
News | Structural Heart

May 20, 2022 — Abbott announced two late-breaking data presentations highlighting both TriClip, a first-of-its kind ...

Home May 20, 2022
Home
News | Structural Heart

May 16, 2022 — Philips, a global leader in health technology, announced at EuroPCR (17 - 20 May 2022, Paris, France) the ...

Home May 16, 2022
Home
News | Structural Heart
April 8, 2022 – Patients who received a transcatheter supra-annular self-expanding heart valve had significantly less ...
Home April 08, 2022
Home
News | Structural Heart

April 7, 2022 – Patients treated with the blood thinner edoxaban for six months after a heart valve replacement ...

Home April 07, 2022
Home
News | Structural Heart

March 24, 2022 — HLT Inc., a Bracco Group Company and a leader in the development of cutting edge transcatheter aortic ...

Home March 24, 2022
Home
News | Structural Heart

Febraury 9, 2022 — Northwestern Medicine McHenry Hospital recently achieved a milestone with the completion of the 100th ...

Home February 09, 2022
Home
News | Structural Heart

January 18, 2022 — Peregrine Ventures, a leading investment firm dedicated to supporting life changing healthcare ...

Home January 18, 2022
Home
News | Structural Heart

January 17, 2022 – As the increasing number of structural heart interventions are assisted by real-time imaging guidance ...

Home January 17, 2022
Home
Subscribe Now