Neurointerventional medtech startup Borvo Medical has received the US Food and Drug Administration (FDA) 510(k) clearance of the Borvo Endoport Vacuum Assisted Collection (EVAC) system.

Borvo EVAC system is a new minimally invasive option for surgical brain treatments. It offers an advanced alternative to traditional subdural haematoma (SDH) drainage methods.

The system addresses the limitations of current brain surgery devices. It utilises fabrication techniques and improved materials to create an ergonomic, efficient, and less invasive solution.

According to Borvo Medical, Borvo EVAC will meet the needs of an ageing population and those needing SDH drainage due to head injuries. It also aims to fill the treatment gaps created by the traditional SDH drainage solutions.

Its advanced technology minimises artifacts on post-operative CT scans, ensuring clearer and more reliable follow-up imaging for medical teams, the neurointerventional medical technology firm said.

Additionally, Borvo EVAC is MRI-compatible, offering a range of imaging and monitoring capabilities without compromising performance.

The system features two unique, patent-pending designs made from 3D-printed non-ferromagnetic titanium. This fabrication allows for a larger lumen and enhanced ergonomics and features.

Borvo Medical founder and CEO Martin Dieck said: “Borvo EVAC represents a significant advancement in the approach to treating subdural hematoma.

“For years, clinicians have relied on traditional devices such as the stainless-steel Subdural Evacuation Port System (SEPS), which, while effective, have not evolved to meet modern demands, including imaging compatibility.

“Our technology not only addresses the limitations of the current standard-of-care, but also transforms the experience for medical professionals and patients.

“Among other advantages, the patent-pending designs of the EVAC system utilises a unique geometry which results in more volume and may lead to less clogging as compared to older technologies.”

The EVAC system is expected to be available in early 2025.

Borvo Medical focuses on advancing minimally invasive neurosurgical technology. The company develops next generation of SDH treatment solutions.

The startup is part of the NeuroTechnology Investors (NTI) portfolio, a California-based physician investment group.

In July, NTI’s another portfolio company, Radical Catheter Technologies, received the FDA 510(k) clearance for Radical Catheter, designed to allow access blood vessels in the brain for both femoral and radial access.