The new Switch and its accessories are considered to be a class III medical device (EU), which is expected to receive CE mark approval within a year after closing of the B-round financing.

Mellon has developed the new platform technology for suturing with one hand. The straight needle in the device enables to suture all tubular and layered structures.

The technology can also be used in a range of other applications, including general surgery, urology, gynecology and neurosurgery.

The disposable precision-suturing instrument can be operated by lightly squeezing the double-action buttons with thumb and index finger of one hand. Other hand will be free to present the tissue to be sutured.

The company said that it anticipates a 510(k) pathway, assuming the regulator would accept a rationale that demonstrates that the technological characteristics of the Switch are substantially equivalent to previously listed devices for general surgical purposes (Class II).

The company is also expecting a premarket approval (PMA) for the intended use in the central circulatory system (Class III in carotid artery surgery).

Mellon intends to develop different dimensions of the hand-held device, to cover the whole range of vascular surgery as well as procedures in other surgical disciplines

Mellon Medical chief medical officer Mark Vrancken Peeters said: “By collaborating with medical specialists, industrial designers and ergonomic experts in the development of the Switch, Mellon has been able to reinvent suturing, bringing suturing technology into the 21st century.

“Our mission is to improve medical procedures by providing the best possible tools. We believe our innovative platform suturing technology will improve patient outcome and reduce overall healthcare costs.”

Image: Mellon Medical’s new Switch disposable precision-suturing instrument. Photo: courtesy of B3C Group GmbH / Mellon Medical.