Borvo Medical has announced US Food and Drug Administration (FDA) 510(k) clearance of the Borvo Endoport Vacuum-Assisted Collection (EVAC) system—an advanced alternative to traditional subdural haematoma (SDH) drainage methods. In addition, Borvo recently presented its innovative technology at the ongoing 17th World Federation of Interventional and Therapeutic Neuroradiology (WFITN) congress (6–10 October, New York, USA).
Designed to address the limitations of existing devices, Borvo EVAC leverages state-of-the-art fabrication techniques, improved materials science, and ergonomic designs, to provide a modernised, efficient and less invasive solution. That is according to a recent press release from the company, which also states that EVAC “meets the evolving needs of an ageing population, and individuals requiring SDH drainage due to head injuries and other causes”.
The EVAC system is anticipated to be available in early 2025, as per Borvo’s recent press release.
“It’s clear that the current SDH drainage systems need an upgrade, especially as the demand for better minimally invasive options increases with the rise of middle meningeal artery (MMA) embolisation,” said Adam Arthur (University of Tennessee/Semmes Murphey Clinic, Memphis, USA). “Borvo presents an opportunity to enhance both safety and effectiveness, which have been limited by the outdated existing options. As a more efficient, imaging-compatible alternative, I am optimistic that Borvo EVAC holds promise to significantly improve neurosurgical practices for patients.”
Borvo EVAC stands poised to fill current gaps in care and transform SDH drainage solutions, according to the company. With advanced technology that reduces artifacts on postoperative computed tomography (CT) scans, it delivers clearer, more reliable follow-up imaging for medical teams. And, unlike existing options, Borvo EVAC is magnetic resonance imaging (MRI)-compatible, providing a broad range of imaging and monitoring options without performance interference.
Additionally, Borvo EVAC employs two unique, patent-pending designs, fabricated with state-of-the-art, 3D-printed, non-ferromagnetic titanium, enabling features and ergonomics—including “a significantly larger lumen, previously unattainable with conventional machining and manufacturing”.
“Borvo EVAC represents a significant advancement in the approach to treating SDH,” said Borvo founder and chief executive officer Martin Dieck. “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 utilise a unique geometry, which results in more volume and may lead to less clogging as compared to older technologies.”
