Haemonetics’ SavvyWire Receives CE Mark Certification

August 1, 2024—Haemonetics Corporation recently announced CE Mark certification and the first commercial European procedures for the SavvyWire pre-shaped pressure guidewire. The SavvyWire guidewire is a sensor-guided 3-in-1 solution for transcatheter aortic valve implantation/replacement (TAVI/TAVR). The company will engage in country-specific entrance of the SavvyWire guidewire into the European Union and other geographies that recognize CE Mark.

SavvyWire® Pre-Shaped Pressure Guidewire - © 2024 Haemonetics Corporation

The first commercial European procedures using the SavvyWire guidewire were performed in July at Hôpital Haut-Lévêque du Centre Hospitalier Universitaire (CHU) de Bordeaux, France, and at Catharina Ziekenhuis in Eindhoven, the Netherlands.

Haemonetics added the SavvyWire guidewire to its product portfolio with the completion of its acquisition of OpSens Inc., which was announced in December 2023.

According to Haemonetics, the SavvyWire guidewire is engineered for procedural efficiency with predictable wire performance, hemodynamic measurement, and left ventricular (LV) pacing capabilities. The 3-in-1 device supports multiple steps over the same guidewire, reducing procedural device exchanges, providing stable aortic valve delivery, and positioning while continuously monitoring cardiac hemodynamics. Additionally, it enables reliable left ventricular pacing without need for adjunct devices or venous access for conventional right ventricular pacing during TAVI/TAVR procedures.

“More than 20 years after the first introduction of TAVI in France, the SavvyWire guidewire brings unique capabilities to European markets to help further streamline and optimize the procedure through efficient, predictable wire performance and LV pacing,” commented Lionel Leroux, MD, from CHU Bordeaux in Haemonetics’ press release.

Professor Thomas Modine, MD, of CHU Bordeaux added, “This wire marks an important step in the assessment of TAVI patients. With one wire in the same position, there are less manipulations, and we are enabled to continuously monitor the patient’s hemodynamics.”

Also in the press release, Professor Pim Tonino, MD, from Catharina Ziekenhuis stated, “The SavvyWire guidewire raises the standard for hemodynamic measurements throughout the TAVI procedure, enabling physicians to make important procedural decisions immediately without having to exchange devices.”