Getinge’s Vasoview Hemopro 3 secures FDA 510(k) clearance: A leap forward in endoscopic vessel harvesting solutions
In a significant development for the medical technology sector, Getinge has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Vasoview Hemopro 3, marking a pivotal moment in the advancement of endoscopic vessel harvesting (EVH) solutions. This clearance underscores Getinge’s adherence to the highest standards of safety and effectiveness, reinforcing its dedication to improving medical technology and healthcare outcomes.
The Vasoview Hemopro 3 is the latest addition to Getinge’s portfolio, designed with a strong focus on customer-centric innovations to boost procedural efficiency in healthcare settings. Elin Frostehav, President Acute Care Therapies at Getinge, highlighted the importance of EVH in facilitating quicker patient recovery, reducing surgical trauma, and minimizing post-operative pain. “EVH is a therapy significantly helping patients towards faster recovery by minimizing surgical trauma and reducing post-operative pain. By offering solutions together with extensive training, we aim to continue help facilitating the widespread adoption of this essential therapy. The new generation of Vasoview – Hemopro 3 – symbolizes our dedication to elevating healthcare standards together with our customers,” Frostehav stated.
The development of the Vasoview Hemopro 3 is the result of comprehensive market research and collaborations with clinicians in the EVH field. The product embodies collaborative innovation, with feedback from these interactions playing a crucial role in its design. Key enhancements of the Vasoview Hemopro 3 include improved smoke evacuation, regulated energy control, an ergonomic game controller style handle, and an integrated cable, all aimed at increasing harvester efficiency and patient outcomes.
Getinge is gearing up for the U.S. launch of the Vasoview Hemopro 3, scheduled for the third quarter of 2024. The company is also in the process of registering the product in additional key markets, indicating a broad-based commitment to enhancing global healthcare standards through innovation.
The FDA’s clearance of the Vasoview Hemopro 3 is a testament to Getinge’s commitment to innovation and quality in the medtech space. This advancement is expected to significantly impact the field of endoscopic vessel harvesting by providing healthcare professionals with a tool that enhances procedural efficiency and patient care. The emphasis on collaboration and feedback from the medical community in the development of this product exemplifies a customer-centric approach that is likely to set a new benchmark in the EVH therapy segment.