Marblehead Medical is another Mayo Clinic offshoot, and it’s getting close to emerging from stealth mode. Its Boss balloon guide catheter received FDA 510(k) clearance on Jan. 28 for treating acute ischemic stroke.
Boss is indicated for use to help with insertion and guidance of an intravascular catheter into a blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The catheter is also indicated for use as a conduit for blood clot-retrieval devices.
The company’s application for an SBIR grant describes its technology as having “crucial usability innovations and a novel balloon material” designed to overcome the limitations of existing clot-removal devices.
“Boss not only has a more durable, compliant, and usable balloon but also increases the inner lumen size without a larger arteriotomy, thus allowing the largest and best retrieval devices to be used without introducing greater hemorrhage risks,” the application says. “Boss achieves this through a more stable braid-and-coil combination device that can be used for both arterial access and flow arrest in the carotid artery, simplifying and speeding stroke procedures.”