Haemonetics’ SavvyWire Pre-Shaped Pressure Guidewire Wins CE Mark

Haemonetics Corporation has gained CE Mark certification and conducted the first commercial European procedures using the SavvyWire Pre-Shaped Pressure Guidewire.

The company touts its SavvyWire guidewire as the world’s first and only sensor-guided three-in-one solution for Transcatheter Aortic Valve Implantation (TAVI), designed to improve procedural efficiency with predictable wire performance, hemodynamic measurement and left-ventricular (LV) pacing capabilities.

“CE Mark certification for the SavvyWire guidewire is a key step in our strategic international expansion, as we continue to broaden our leadership and impact by creating greater access to critical interventional technologies that advance healthcare standards,” said Stewart Strong, president, Global Hospital, at Haemonetics. “We look forward to leveraging our strong global commercial infrastructure to bring the SavvyWire guidewire’s fiber optic sensor technology to Europe, the Middle East and Africa, and enable more physicians to optimize TAVI procedures to improve patient outcomes.”
 
Haemonetics added the SavvyWire guidewire to its product portfolio with its acquisition of OpSens Inc. in December 2023. With CE Mark approval, the company can now introduce the SavvyWire guidewire into the European Union (EU) and other geographies that recognize CE marking. The first commercial European procedures using the SavvyWire guidewire were performed at Hôpital Haut-Lévêque du Centre Hospitalier Universitaire (CHU) de Bordeaux, France, and at Catharina Ziekenhuis Eindhoven in The Netherlands.

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“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,” said Dr. Lionel Leroux from CHU Bordeaux.

Professor Thomas Modine 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 haemodynamics.”

The SavvyWire guidewire is engineered to uniquely support multiple steps over the same guidewire, reducing procedural device exchanges, providing stable aortic valve delivery and positioning while continuously monitoring cardiac hemodynamics. Additionally, it has been designed to enable reliable LV pacing without need for adjunct devices or venous access for conventional right ventricular pacing during TAVI procedures.
 
“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,” stated Professor Pim Tonino from Catharina Ziekenhuis Eindhoven.
 
Haemonetics is a global healthcare company whose technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. Haemonetics’ Global Hospital business provides a range of solutions to address the needs of hospitals, including interventional technologies for electrophysiology and interventional cardiology, and blood management technologies that include diagnostics to help inform treatment decisions, technologies to help avoid unnecessary allogeneic transfusions and solutions to help optimize management of blood products.