Nobles Medical Technologies II has announced that the US Food and Drug Administration (FDA) has granted the approval to conduct a prospective pivotal clinical trial, dubbed STITCH.

The company said that its STITCH study is aimed at providing data for indication of Patent Foramen Ovale (PFO) closure for the reduction of recurrent ischemic stroke.

PFO is a common heart defect formed as a trace of the foetal circulation, and characterised by an unsealed tunnel between the right and left atria of the heart.

During the development of heart chambers, a channel (foramen ovale) is formed between the right and left atria, facilitating the blood to flow directly from the venous circulation to the arterial circulation, circumventing the non-functioning foetal lungs.

After the birth, the foramen ovale is completely closed within the first few months, due to the change in pressure differential between the right and left atria with and newly operational blood flow to the fully functioning lungs.

In some cases, the foramen ovale fails to seal and remains patent, with a Patent Foramen Ovale (PFO), and it may reopen under increased atrial pressure through coughing, or straining.

Nobles Medical Technologies II is planning to start enrolling patients by October 2019

The NobleStitch EL is a medical device that places a suture into the 2 atrial septal walls and closes them with a small implantable polypropylene knot. It is located in the right atrium and leaves nothing in the left atrium.

STITCH is a comparative trial with comparing the safety and effectiveness of the NobleStitch EL suture-based closure system for PFO closure with the FDA approved Amplatzer PFO Occluder, a metal implant placed in the left and right atrium, as primary endpoints.

The primary endpoints the trial would compare the closure rates and safety events at 6 months follow-up for the 2 devices before the NobleStitch EL data submission for approval of the new indication.

STITCH principal investigator Thompson said: “I have not been this excited since medical school.  PFO closure is an important part of structural heart treatment and this study will provide invaluable data about both devices.”

In April 2017, NobleStitch EL was cleared for the indication for cardiovascular suturing. It secured CE mark in Europe for PFO closure in 2012.

Nobles Medical Technologies II chairman and CEO Anthony Nobles said: “This is an important milestone for our company and our technology. Our team has worked for more than 2 years on this IDE.”