|St. Jude's Portico transcatheter aortic heart valve--Courtesy of St. Jude|
St. Jude Medical ($STJ) completed the first U.S. implants of its transcatheter aortic valve system, moving the company one step closer to winning coveted stateside approval for its device.
The Minnesota-based company conducted the implants as part of an ongoing Investigational Device Exemption (IDE) trial for its Portico re-sheathable transcatheter aortic valve, a device that treats patients with severe aortic stenosis who are too frail for open-heart surgery. Physicians at New York's Lenox Hill Hospital and Los Angeles' Cedars-Sinai Heart Institute implanted the Portico valves using transcatheter aortic valve replacement (TAVR) procedures, delivering the device via a transfemoral artery while a patient's heart is still beating.
Unlike many TAVR systems, Portico can be repositioned at the implant site, allowing for more precise placement and less procedural risk, Dr. Raj Makkar, director of Interventional Cardiology at Cedars-Sinai Heart Institute in Los Angeles, said in a statement.
"We have received positive feedback on the advanced features of the Portico valve from the experienced physicians who have used it. The Portico valve is an attractive option that will enable interventional cardiologists and cardiac surgeons who perform TAVR procedures to treat patients who might not otherwise be eligible for surgery," St. Jude Chief Medical Officer Dr. Mark Carlson said in a statement.
St. Jude plans to continue randomized trials of its Portico device at up to 40 sites in the U.S., and submit data for FDA approval. The company already achieved a CE mark for its 23 mm transcatheter aortic heart valve in 2012 and won European approval for its 25 mm model in December 2013. The device is limited to investigational use in the U.S.
Positive study results help St. Jude compete in a saturated market, as big names like Medtronic ($MDT) and Boston Scientific ($BSX) are developing their own TAVR products. Boston Scientific recently presented favorable clinical trial results for its Lotus device, and Medtronic touted new data from a study showing that its CoreValve system was effective in treating high-risk patients. Medtronic also won a major battle its ongoing TAVR patent war with Edwards Lifesciences ($EW) in April, as the company warded off an injunction that would have prevented it from marketing CoreValve in the U.S.
While larger device outfits dominate the market, smaller operations are also looking for a cut of the profits. Venture-backed upstart JenaValve bagged new funding for its transcatheter aortic valve implantation (TAVI) system in April, adding $10 million to a previous $62.5 million round. The 2013 Fierce 15 honoree is planning to launch a leg-implanted transfemoral model of the device in Europe next year.
- read the release