Haemonetics Earns CE Mark for VASCADE® Vascular Closure Product Portfolio
Haemonetics Corporation (NYSE: HAE) announced it has received CE mark certification for its VASCADE® vascular closure and VASCADE MVP® venous closure systems. This certification enables the company to launch these products in the European Union and other regions recognizing CE marking. The VASCADE system is tailored for small-bore femoral closure in various medical procedures, while VASCADE MVP is designed for mid-bore closures, particularly after cardiac ablation. Both systems aim to improve patient outcomes and hospital efficiency.
- CE mark certification allows entry into the EU market for VASCADE products.
- The VASCADE MVP is the only FDA-approved closure device for same-day discharge after cardiac ablation.
- Strong growth observed in Haemonetics' Hospital business due to VASCADE product line.
- Entry into the EU may face regulatory and market acceptance challenges.
- Potential risks from global economic conditions affecting product launch timelines.
BOSTON, Sept. 12, 2022 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, today announced it has earned 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 recognize CE marking.
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 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 hemostasis faster with fewer complications on average.
In 2021, VASCADE MVP became the first and only vascular closure device to receive 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 commercializing 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."
"The growth Haemonetics has seen in its Hospital business as a result of the VASCADE product line has been tremendous," said Chris Simon, Haemonetics' President and CEO. "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."
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with its VASCADE and VASCADE MVP products and Haemonetics' plans or objectives related to the development and commercialization of these products. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the impact of the COVID-19 pandemic, including its scope and duration; government actions and restrictive measures implemented in response and associated economic disruptions, including inflationary pressures and higher freight costs in our global supply chain; product quality; market acceptance; regulatory uncertainties, including in the receipt or timing of regulatory approvals; the effect of global economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.
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SOURCE Haemonetics Corporation
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