Staff Writer

Edwards Lifesciences (Irvine, Calif.) has won FDA approval for a valve-in-valve indication for the Sapien XT. The approval opens up the door for Edwards to address an additional patient population that its rival Medtronic (Dublin) already had access to through its Corevalve Evolut valve.

News first broke of the approval on the last day of the Transcatheter Cardiovascular Therapeutics annual meeting, where Edwards released one-year patient outcomes that were presented for patients treated with transcatheter Sapien XT valve implantation in surgical tissue valves. The valve-in-valve procedure was associated with a high overall one-year survival rate of 86.6 percent and a low overall stroke rate of 3.7 percent in a very high-risk patient population, according to independently adjudicated data from the 197-patient PARTNER II Valve-in-Valve study. The study, which is a multi-center, non-randomized cohort of The PARTNER II Trial, included 97 patients enrolled in the primary registry as well as 100 continued access patients.

One of the things that were interesting from this data set was when we looked at the functional class of patients, which is measuring their quality of life and how they feel, they were some of the worst patients we have seen, Larry Wood, corporate VP, Transcatheter Heart Valves, Edwards Lifesciences, told Medical Device Daily. They were very sick to where they were almost debilitated even at rest. To be able to do a procedure like this that can be done off pump without going into the sternum again, and be done very quickly, with shorter recovery times, we [were able] to see a major improvement in their quality of life and their functional class.

Wood said the approval was also significant because it addresses off-label use of the device.

What s also important about this approval is that a number of physicians across the country have been doing this procedure off-label, which is tough because we can t support their cases or provide any advice for them, he said.

Wood said the market size for the valve-in-valve indication was fairly small.

This is certainly not anywhere the size of the native aortic stenosis market, this is more of a small niche-like procedure, he said. For patients who have this condition it is an incredibly important procedure for them to have. We don t think about this procedure so much in terms of market growth . . . and we certainly don t think about it from a share perspective.

The company received CE mark for valve-in-valve procedures for Sapien XT in February of last year. A spokeswoman for Edwards told MDD the company eventually plans to seek FDA approval for valve-in-valve procedures for Sapien 3.

Medtronic, Edward s chief rival in the TAVR market received FDA approval for valve-in-valve procedures back in March. During TCT, the company released data from a 6,160-patient study on Corevalve in the TVT registry, run by the Society of Thoracic Surgeons and American College of Cardiology. The data from the study shows the rate of 30-day all-cause mortality was 5.2 percent, and the stroke rate was 2.6 percent.

Medtronic gained access to the device when it acquired Corevalve for $700 million plus additional milestone payments in 2009 (Medical Device Daily, Feb. 24, 2009).

The question of valve-in-valve for younger patients arose during TCT 2014 in a discussion involving Michael Mack of Baylor Heart Center (Dallas) and Nicolo Piazza of McGill University (Montreal). Mack said during the discussion that cardiologists were already considering the use of larger valves as a first TAVR treatment in order to make room for a second valve, citing a 23 millimeter valve as a possible minimum diameter for the first valve (MDD, Sept. 19, 2014).

Mack had framed the question in terms of a 40-year old patient, describing a scenario in which such a patient might need another valve a decade later, then a third one another 10 to 15 years farther out. In this scenario, you have a 60-65 year old patient doing their first operation via surgical AVR, Mack said, adding that the fourth valve could be another TAVR device. He stated that such an approach takes the patient to the age of 85 or so with only one surgical procedure, although he noted that one potential problem is a need to replace the aortic root, which he said indicated is more likely in patients with self-expanding valves.

TAVR in 2015

This has been a tremendous year for both Edwards and Medtronic in the TAVR space. In March, Corevalve received approval and in June Edwards gained approval for Sapien 3.

The approvals of the Sapien 3 and Corevalve Evolut R highlight the increasing adoption and acceptance of TAVR within the medical community as a standard treatment option for valvular heart disease patients, said Premdharan Meyyan, Globaldata s analyst covering medical devices. Furthermore, they will give Edwards Lifesciences and Medtronic an edge over other TAVR players, such as Boston Scientific [Marlborough, Mass.] and Symetis [Ecublens, Switzerland] which have also been attempting to seize shares in a growing market expected to be worth $3.02 billion by 2020.

Shares of Edwards (NYSE:EW) closed at $151.28.

No Comments