Medical device company Saranas is seeking de novo classification from the US Food and Drug Administration (FDA) for its Early Bird bleed monitoring system.
The company submitted an application requesting the agency to review it.
The technology, which was invented at the Texas Heart Institute, allows for the early detection and monitoring of bleeding complications associated with vascular access procedures.
The Early Bird bleed monitoring system allows physicians to mitigate downstream consequences by addressing bleeding complications immediately, resulting in enhanced patient outcomes and reduced healthcare costs.
It includes a vascular access sheath with embedded sensors that measure the electrical resistance across the blood vessel.
By sensing a change in the vessel’s electrical resistance, the system is designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, including transcatheter aortic valve replacements.
Saranas president and CEO Zaffer Syed said: “This submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, design verification testing, and preclinical animal studies.
“We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance.”
Saranas focuses on enhancing patient outcomes via early detection and monitoring of internal bleeding complications.
In June 2017, Saranas raised $4m in a Series B round of financing to advance the Early Bird Bleed Detection device through final product testing and FDA submission.
The company said that more than 20 million patients in the US undergo vascular access procedures every year.
Saranas noted that about one million of those patients, or 5%, experience a severe bleeding complication, resulting in more healthcare expenditures and placing the patient at an increased risk of death.
It is difficult to notice the blind bleeds until meaningful symptoms are present, which in some cases results in compromising patient outcomes.
Image: FDA Laboratory Building 62 (Engineering and Physics) houses the Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.