St. Jude Medical Inc. has received permission to resume sales of its catheter-delivered aortic valve in Europe, but it’s still working with American authorities to restart clinical testing of the device in the U.S.
The Little Canada company is under competitive pressure to bring its device, called Portico, to market as soon as it can. It chose to halt its domestic clinical trial and paused European sales in September, however, after diagnostic images showed unexplained motion in the valve’s leaflets.
In an e-mail, company spokesman Justin Paquette said Thursday that St. Jude officials and outside experts have studied the data and are satisfied that the leaflet motion is not leading to complications or an excess of what he called “clinical events” for patients.
“Patients with the leaflet observation were found to be asymptomatic,” Paquette said.
The motion was detected in computed-tomography (CT) scans in some U.S. clinical-trial patients who received St. Jude’s investigational device, as well as some patients in the control group.
After a review by regulators, European officials this week reinstated the CE Mark approval for the device to be used commercially and in research. The company is also in discussions with the U.S. Food and Drug Administration to restart its clinical trial of the device in patients with diseased aortic valves who are not good candidates for major heart surgery.
Heart valves implanted using thin catheters in the arteries, rather than through open-chest surgery, are expected to generate billions of dollars of sales growth in coming years. It’s seen as a technological advancement because the clinical trials so far show that delivering valves by catheter is just as safe as traditional surgery but requires much less recovery time for patients.
All of Minnesota’s big heart-device companies are working on transcatheter aortic valve replacement systems. Fridley’s Medtronic is in the process of testing its second-generation device, and major Twin Cities employer Boston Scientific hopes to have its first system approved in the U.S. by 2017.
The company with the longest tenure in catheter-delivered heart valves is California’s Edwards Lifesciences. At the American College of Cardiology annual meeting in San Diego on Sunday, Edwards is slated to present the final results of the only study to follow catheter-delivered aortic valve patients for five years after the procedure.