Getinge takes a leap forward in cardiovascular surgery with the 510(k) clearance for Vasoview Hemopro 3

2024-03-08

上市批准

GOTHENBURG, Sweden, March 8, 2024 /PRNewswire/ --

Today, Getinge announces the U.S. Food and Drug Administration's (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company's endoscopic vessel harvesting (EVH) solutions. Designed with customer centricity top of mind, the newcomer is expected to offer enhanced procedural efficiency in healthcare from the upcoming launch.

Receiving the FDA 510(k) clearance for Vasoview Hemopro 3 marks a significant milestone for Getinge and underscores the effort to comply with the highest safety and effectiveness standards, emphasizing the medtech company's commitment to advancing medtech.

"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," says Elin Frostehav, President Acute Care Therapies at Getinge.

The culmination of extensive market research and advisory boards conducted in partnership with clinicians within the EVH field, Vasoview Hemopro 3 represents collaborative innovation. Feedback from the studies has been central in shaping the product, focusing on improvements that enhance harvester efficiency and patient outcomes. Advancements include enhanced smoke evacuation, regulated energy control, ergonomic game controller style handle, and an integrated cable.

Getinge is preparing for the product launch of Vasoview Hemopro 3 to occur in the US during the third quarter of 2024, while registration in additional key markets is underway.

Investor Relations:

Lars Mattsson, Head of Investor Relations

Phone: +46 10 335 0043

Email: [email protected]

Media contact:

Caroline Örmgård, Head of Public & Media Relations

Phone: +46 10 335 0041

Email: [email protected]

About Getinge

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/getinge/r/getinge-takes-a-leap-forward-in-cardiovascular-surgery-with-the-510-k--clearance-for-vasoview-hemopr,c3943030

The following files are available for download:

SOURCE Getinge

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构