Borvo Medical Receives 510(k) Clearance for Surgical Device

Borvo Medical, a neurointerventional medtech startup, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Borvo (Endoport Vacuum Assisted Collection) EVAC system, an advanced alternative to traditional subdural hematoma (SDH) drainage methods. The EVAC system is anticipated to be available in early 2025.
 
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 modernized, efficient, and less invasive solution. The EVAC meets the evolving needs of an aging population and individuals requiring SDH drainage due to head injuries and other causes. 
 
SDH is a type of bleeding inside the head that can be life-threatening, and has become increasingly common due to head injuries, brain atrophy, and the use of blood thinners. Treatment involves drainage to remove blood or fluid buildup on the brain’s surface. Traditionally, these procedural options usually include either making an opening in the skull or drilling holes to drain the fluid.
 
Borvo EVAC aims to transform SDH drainage solutions with advanced technology that reduces artifacts on postoperative CT scans. It delivers clearer, more reliable follow-up imaging for medical teams. This MRI-compatible system provides a broad range of imaging and monitoring options without performance interference. 
 
“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,” said Martin Dieck, Founder and CEO of Borvo Medical. “Among other advantages, the patent-pending designs of the EVAC system utilizes a unique geometry which results in more volume and may lead to less clogging as compared to older technologies.”
 
Also, 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.
 
“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) embolization. Borvo presents an opportunity to enhance both safety and effectiveness, which have been limited by the outdated existing options,” said Dr. Adam Arthur, the James T. Robertson Endowed Professor and Chair of the Department of Neurosurgery at the University of Tennessee and Semmes-Murphey Clinic. “As a more efficient, imaging-compatible alternative, I am optimistic that Borvo EVAC holds promise to significantly improve neurosurgical practices for patients.”
 
The company will present its innovative technology at the 17th World Federation of Interventional and Therapeutic Neuroradiology (WFITN) Congress in New York from October 6-10, 2024.