#FDA Approval #Boston #Haemonetics #PerQseal Elite

Haemonetics Receives FDA Approval for PerQseal® Elite Vascular Closure System

Haemonetics Corporation, a global leader in medical technology, proudly announces that it has received FDA approval for its innovative PerQseal® Elite vascular closure system. This advancement is set to significantly improve the landscape of large-bore arterial procedures, further establishing Haemonetics’ reputation in delivering groundbreaking solutions that enhance patient outcomes.

Overview of PerQseal® Elite

The PerQseal Elite system stands out due to its unique ability to facilitate sutureless vascular closure. Specifically designed for large-bore arterial procedures utilizing sheaths ranging from 14 to 22F, the device is equipped with a fully bioabsorbable patch. This patch effectively seals arteriotomies of up to 26F from the interior of the blood vessel, enabling rapid hemostasis and ensuring no permanent materials are left inside the patient's body.

One of the key advantages of the PerQseal Elite is its operational flexibility. Physicians can confirm the hemostatic effect while still maintaining guidewire access. Furthermore, the system allows for adjustments or recovery until the moment of implant release, providing unprecedented control during procedures.

Clinical Validation

Recent clinical trials, particularly the prospective, single-arm, multicenter ELITE arterial study, showcased the efficacy of the PerQseal Elite. The results indicated an impressive 0% rate of major device-related complications, as per VARC-3 standards, and a mean time to achieve hemostasis of under one minute. Such data underscores the system's reliability and speed, crucial factors in high-stakes medical environments.

This system has not only gained traction in the United States; it previously received CE Mark approval in Europe in 2025 for both arterial and venous applications, reflecting its compatibility and effectiveness across varying medical practices.

Strategic Importance for Haemonetics