New 8-French 25cm Device Receives FDA 510k clearance
Endophys Holdings LLC, a developer of innovative sheath-based blood pressure monitoring technology, has announced the launch of its newest Pressure Sensing Access System (PSAS). The new product is an 8-French 25cm access sheath, designed to provide deeper access to the femoral artery, while measuring intra-arterial blood pressures at a rate of 1,000 times per second.
Bringing analog blood pressure monitoring to the digital age, the Endophys system features a small fiber optic pressure sensor embedded in the wall of the access sheath, making it possible to simultaneously monitor blood pressure while also using the sheath for performing a range of vascular procedures.
Endophys’ patented blood pressure monitoring device feeds data directly into the patient care monitor, giving the medical staff continuous pressure readings in real time, more accurately than a traditional arm cuff. In addition, the system offers pressure readings down to true zero and eliminates the need for a separate radial arterial line for invasive monitoring.
“We're excited about the new availability of the 8F 25cm sheath,” said Dr. Phil Purdy, inventor of the Endophys technology. “Based on feedback from customers, this should help in stroke therapy and other applications by giving direct aortic access via the sheath, helping improve the platform stability for interventions done in remote locations.”
Endophys Holdings, LLC (www.Endophys.com) has pioneered a novel blood pressure monitoring technology that connects directly to standard patient care monitors. The 8-French, 25cm Pressure Sensing Access System is the company’s fourth commercial product. The Company has previously received FDA clearance for it’s proprietary pressure monitor with direct connectivity to the patient care monitor, as well as three other pressure sensing access sheath products.
The Company’s aim is to provide best-in-class blood pressure monitoring for improved treatment in stroke, cardiac, and trauma cases. Independent studies have shown that a decrease in blood pressure is associated with unfavorable outcomes in patients undergoing thrombectomy under general anesthesia.