Vivasure’s PerQseal Closure Device Evaluated in Initial Results From PATCH Pivotal Study

November 3, 2024—Vivasure Medical recently announced initial positive results from its PATCH pivotal study conducted in the United States under an investigational device exemption, evaluating the safety and efficacy of the Vivasure PerQseal closure device system.

The findings showed that the device achieved closure with very low rates of major vascular complications and rapid times to hemostasis, stated Vivasure, which further noted that the data from the study will support a premarket approval submission to the FDA.

The initial PATCH findings were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to the company, the multicenter, single-arm PATCH pivotal study enrolled more than 145 patients at 17 sites in the United States and Europe. The study is evaluating the safety and efficacy of PerQseal when used to achieve hemostasis of common femoral arteriotomies created by 12-F to 22-F sheaths (arteriotomies up to 26 F) in patients undergoing percutaneous catheter-based interventional procedures.

As summarized in the company’s press release, the data presented at TCT demonstrated a Valve Academic Research Consortium 3 (VARC-3) major complication rate of 0.8% at discharge in 124 patients included in the study’s primary intention-to-treat analysis. Times to hemostasis after percutaneous procedures were rapid, with a median time of 0 minutes.

William A. Gray, MD, who is system chief in the division of cardiovascular disease at Main Line Health in Philadelphia, Pennsylvania, serves as principal investigator of the PATCH study.

“Complications from large-hole vascular closure remain vexing, impacting patients and requiring additional time and resources,” commented Dr. Gray in Vivasure’s press release. “As interventionalists, we need new technologies to improve both outcomes and procedural efficiency. The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”