Clinical trial brings US medical device firm one step closer to market
Medical device company Innovative Cardiovascular Solutions is one step closer to bringing its latest product to market due to the launch of a European clinical trial, MiBiz reports.
If the trial is successful the company could gain regulatory approval to sell its Emblok Embolic Protection Catheter in Europe. This in turn would help Innovative Cardiovascular Solutions gain FDA approval in the US.
The device is designed for use in transcatheter aortic valve replacement procedures. It collects debris in the blood during the procedure, preventing a potential stroke or neurocognitive damage.
The trial will involve patients receiving an MRI prior to the procedure and a follow-up scan afterward to check for particulate in the brain. The procedure treats patients with aortic stenosis, a narrowing of the aortic valve opening that restricts blood flow in the heart.
The European clinical trial will take around three months and will involve 30 patients. CEO Kevin Plemmons stated that the first use of the device in patients at hospitals in Italy “went great”.
“It’s really great to see the effort of the last four years come to fruition. We’ve been working on this device diligently and have made countless changes to the device, and we now have the final device to bring to market, if that opportunity presents itself.”
Patients who undergo transcatheter aortic valve replacement are at risk of stroke and neurocognitive issues. The company state that its device helps protect from stroke and also the potential for neurocognitive problems that can result from partial blockages or debris in the brain.
The company is hoping to pursue a small US clinical trial in the future.