The FDA has granted Nobles Medical Technologies II approval to conduct a prospective pivotal clinical trial for the expanded indication of patent foramen ovale (PFO) closure for reduction of recurrent ischemic stroke, according to the company.
The FDA cleared the NobleStitch EL for cardiovascular suturing in April 2017. It was CE marked in Europe for PFO closure in 2012, where it has been available since 2015, according to the Fountain Valley, Calif.-based company.
A PFO is a congenital heart defect in which a hole in the heart that normally seals at birth remains open. The NobleStitch EL is designed to place a suture into the two atrial septal walls (the septum primum and the septum secundum) and tie them closed with a small implantable polypropylene knot, which is located in the right atrium, leaving nothing in the left atrium.
The clinical trial will compare the safety and effectiveness of using NobleStitch EL’s suture-based PFO closure system to Abbott’s (NYSE:ABT) FDA-approved Amplatzer PFO Occluder, a metal umbrella-type implant placed in the left and right atriums. Investigators will study closure rates and safety events at six months follow-up for the two devices before Nobles Medical submits the data for approval of its device for the new indication.
The FDA cleared the Amplatzer PFO Occluder, developed by St. Jude Medical, in 2016. Abbott acquired St. Jude the following year.
Nobles Medical expects to start enrolling patients as early as October 2019 at its first US center in Virginia.
“I have not been this excited since medical school,” said principal investigator Dr. Jim Thompson in a news release. “PFO closure is an important part of structural heart treatment and this study will provide invaluable data about both devices.”