Medtronic Strata
This article was originally published in The Gray Sheet
Executive Summary
Hydrocephalic shunting device gains 510(k) clearance for draining excess cerebrospinal fluid from the brain. The device consists of a proximal catheter that goes into the brain cavity containing cerebrospinal fluid and a distal catheter to take the excess fluid to the peritoneal cavity to become reabsorbed by the body. The components are connected by a pressure valve to regulate the rate of cerebrospinal drainage. Key features include an ability to adjust the device's five pressure settings non-invasively and without X-ray verification as the patient's condition changes, as well as a siphon control system that protects against excess drainage of cerebrospinal fluid, potentially reducing the frequency of valve replacement and limiting exposure to radiation. The device addresses an annual market of 16,000 patients worldwide who receive a hydrocephalic shunt...