|Edwards Lifesciences' Sapien XT--Courtesy of Edwards|
Edwards Lifesciences ($EW) nabbed an expanded indication for its Sapien XT TAVR from the FDA, putting the device on par with Medtronic's ($MDT) CoreValve, which obtained the indication for so-called valve-in-valve procedures in March.
The expanded indication enables the Sapien XT to be used to replace failed aortic valves with the Sapien valve. As is always the case for TAVRs, the permission is limited to frail patients who are high risk for open-heart surgery.
The FDA granted permission for valve-in-valve procedures to Edwards' second-generation Sapien XT, not its latest generation Sapien 3, which earned FDA approval in June.
An Edwards spokeswoman the company will seek FDA approval for the expanded indication in the Sapien 3 as well, but said the company does not have any information about when that may occur.
Meanwhile, Medtronic said in an email that the valve-in-valve indication granted to it March also covers its latest generation CoreValve Evolut R.
The FDA's move regarding the Sapien XT eliminates a significant advantage held by Medtronic's CoreValve. "As CoreValve is the only TAVR product approved for this (valve-in-valve) indication, it makes CoreValve an indispensable offering for every practicing TAVR center," Medtronic CFO Garry Ellis boasted back in June during an earnings call.
During the Transcatheter Cardiovascular Therapeutics conference in San Francisco, Edwards said that the Sapien XT achieved a one-year survival rate of 86.6% and overall stroke rate of 3.7% among a very high-risk patient population of 197 non-randomized valve-in-valve patients.
"We were very pleased to see 100% survival at 30 days with the 100 high-risk patients treated with the SAPIEN XT valve-in-valve procedure in the continued access registry," said Dr. Danny Dvir, who presented the data at TCT, in a statement. He is an interventional cardiologist at the Center for Heart Valve Innovation at St. Paul's Hospital in Vancouver.
Edwards also presented data at TCT on one-year outcomes data from its latest-generation Sapien 3. The device achieved an overall one-year survival rate of 89.3% and disabling stroke rate of 2.4%, according to a 583-patient U.S. study.
"These excellent results with the SAPIEN 3 valve support the use of TAVR as the preferred therapy for patients at high or greater risk for surgical aortic valve replacement," said Dr. Howard Herrmann, the director of UPenn Medicine's Interventional Cardiology Program and presenter at TCT, in a statement. "The combination of new design features of the SAPIEN 3 valve, procedural improvements, operator experience and improved patient selection have all contributed to strikingly low rates of one-year mortality, as well as other important adverse events, including stroke, in high-risk and inoperable patients with severe aortic stenosis."
Meanwhile, among 6,160 patient on Medtronic's CoreValve in the TVT registry, run by the Society of Thoracic Surgeons and American College of Cardiology, the rate of 30-day all-cause mortality was 5.2%, and the stroke rate was 2.6%, the company announced at TCT.
Those patients don't include recipient of its latest generation CoreValve Evolut R. Recipients of that device had a 6.7% all-cause mortality rate, the lowest of any TAVR at one year follow-up, according to Medtronic. The one-year stroke rate among the 60 patients in the device's CE study was 3.4%.
The expanded indication is solid incremtal achievement for Edwards that will help it compete with Medtronic in the U.S. Both have long been permitted to use their TAVRs for valve-in-valve procedures in Europe.
An intermediate-patient risk indication would be a far bigger breakthrough, and both bigwigs have been presenting data to convince the FDA to give it to them. In a July earnings call Edwards said it is anticipating a potential intermediate risk approval for Sapien 3 in late 2016.
- read the release about the expanded indication
- here's more about the Sapien 3 data from TCT
- here's more about Medtronic's CoreValve Evolut R from TCT