W.L. Gore now has final U.S. regulatory approval to add a second product to an ongoing 700-patient pivotal clinical trial exploring whether its devices designed to close a hole in the heart help reduce recurrent stroke risks.
The FDA gave the final go-ahead to add the company's next-generation Septal Occluder to its REDUCE clinical study. The effort already includes the company's Helex Septal Occluder, and both are being tested as a treatment for patients with patent foramen ovale (PFO), a hole in the heart that creates higher stroke risks.
Gore, initially known for its Gore-Tex ski weather fabrics, has had a CE mark since June 2011 to use the next-generation Septal Occluder for PFO patients and also atrial septal defect (ASD) closure procedures. Gore last week separately launched a clinical study to test its next-generation device for the ASD indication. Its older Helex device has had U.S. approval for use with ASD for some time. Expanded indications for both will help reach a much broader class of patients and also help carve out a larger market share for the products.
The REDUCE study is enrolling 700 patients from 50 different hospitals in the U.S and Europe, according to the company' s website. Plans call for testing whether using both devices to treat PFO, plus medication, are better at reducing the risk of subsequent strokes, compared to just medication and leaving the PFO alone. The results, if successful, will support a U.S. regulatory filing for the PFO indication, the company notes.
- read the release
- check out REDUCE trial details