The CE mark approval will allow the Boston-based company to enter specific markets in the European Union, as well as other regions that recognize the regulatory marking.
Haemonetics designed the Vascade system for small-bore femoral arterial and venous closure that is used in interventional cardiology and peripheral vascular procedures. It designed the Vascade MVP system for mid-bore multi-access femoral venous closure, which is typically used in electrophysiology procedures. It is also FDA-approved for use following cardiac ablation procedures that require two or more access sites in the same limb.
“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 commercializing in the market,” Stew Strong, president of Haemonetics’ global hospital division, said in a news release. “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.”
Both of Haemonetics’ devices have a collapsible disc technology and a reservable collagen patch that helps achieve hemostasis. The company designed them to save time for hospital staff while helping patients reach hemostasis faster.
“The growth Haemonetics has seen in its Hospital business as a result of the Vascade product line has been tremendous,” President and CEO Chris Simon said. “Bringing this product to the EU will continue to distinguish our company for new and innovative solutions that enhance the efficiency and effectiveness of care while improving hospital economics and the patient experience.”