Haemonetics Corporation has received CE mark certification for its Vascade vascular closure and Vascade MVP venous vascular closure systems.
The CE marking will allow Haemonetics to engage in the next steps of country-specific entrance of both products into the European Union (EU) and forms the basis for entry into other geographies that recognise CE marking, the company said in a press release.
The Vascade system is designed for “small-bore” femoral arterial and venous closure, generally used in interventional cardiology and peripheral vascular procedures. The Vascade MVP system is designed for “mid-bore” multi-access femoral venous closure—generally used in electrophysiology procedures—and is the only US Food and Drug Administration (FDA)-approved closure device for use following cardiac ablation procedures requiring two or more access sites within the same limb. Both devices include proprietary collapsible disc technology and a resorbable collagen patch to achieve hemostasis. Vascade and Vascade MVP are designed to save time for hospital staff, while helping patients reach haemostasis faster with fewer complications on average.
In 2021, Vascade MVP received an FDA indication for same-day discharge following atrial fibrillation (AF) ablation. While not all countries in the EU are able to offer same-day discharge to patients, all patients can benefit from the quicker time to ambulation and reduced discomfort that this product provides.
“We see a significant opportunity to bring the advantages of our unique vascular closure products to hospitals within the EU, and look forward to taking steps towards commercialising in the market,” said Stew Strong, president, Global Hospital at Haemonetics. “With the VASCADE portfolio earning CE mark certification, we can meaningfully improve hospital operations throughout the region and further our goal of raising the standard of care for patients around the globe.”