Edwards Lifesciences Corp. plans to rapidly train heart teams over the next two quarters to support the transapical delivery of its Sapien transcatheter heart valve following the recent expanded approval by FDA.

The device gained PMA approval on Oct. 19 for use in patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death. The approval allows valve delivery via both the transfemoral (via the leg artery) and transapical (through the ribs) routes.

Sapien is the only FDA-approved transcatheter aortic heart valve device. It was originally approved last year for patients deemed inoperable by conventional open valve replacement surgery, via the transfemoral approach only. (See Also see "Edwards Wins Approval For Sapien Just In Time For TCT" - Medtech Insight, 7 November, 2011..) And now it is the first such valve to be approved by FDA for transapical delivery. The device is already delivered via both routes in Europe.

Supporting Sapien’s new PMA approval is data from the high-risk cohort (cohort A) of the company’s PARTNER trial, which showed that the survival of high-risk patients treated with Sapien was non-inferior to those treated with traditional open heart surgery. (See Also see "Getting Set For Sapien: With Data In, Discussion Moves To Adoption Dynamics" - Medtech Insight, 11 April, 2011..)

Segments of the clinical community questioned whether the cohort A data, including various sub-analyses, showed strong enough results for transapical delivery to warrant approval. But data from the trial’s continued access protocol showed continued improvements in the outcomes of patients treated transapically. (See Also see "The Latest On Transapical: Edwards Talks Up Sapien CAP Data" - Medtech Insight, 6 February, 2012..)

So far, Edwards says it has trained about 150 commercial centers in the U.S. on the transfemoral Sapien procedure, as well as 36 sites involved in its PARTNER trial, yielding a total of 186 centers that have been trained as of Sept. 30.

The company said during its Oct. 19 third-quarter earnings call that it would begin shipping the transapical units immediately. Uptake would be swift for the transapical delivery route at PARTNER sites because those physicians are already trained on the approach, the firm said.

Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical route.

“With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the Sapien valve,” Edwards said following FDA approval.

The company reported Q3 net sales of $448 million, up 8.5% on a reported basis from $413 million in 2011’s third quarter. Sales growth excluding the impact of foreign exchange was 14%, driven by Sapien’s initial U.S. launch, the company reported.

Transcatheter heart valve sales alone were $124 million, reflecting 66% underlying growth, also driven by the U.S. launch of Sapien. Transfemoral systems represented nearly 80% of the company’s global THV sales. Sapien has been approved in Europe for both transapical and transfemoral delivery since 2007.

The Sapien transcatheter aortic valve replacement procedure can be performed using atransapical delivery through an incision in the rib cage.

Photo: Edwards Lifesciences

Stalled Success For Sapien

Despite the revenue growth, the transcatheter valve growth rate in the quarter “was less than we expected,” said CEO Michael Mussallem. He blamed the shortfall on a combination of continued austerity measures in Europe and a slight delay in FDA’s expanded approval. Edwards had anticipated that the approval would come during the third quarter, which ended Sept. 30.

The firm also lost revenue opportunity due to lack of Medicare coverage for the transapical approach, even if a physician had wanted to apply the transapical technique to an inoperable patient without femoral access. The Medicare policy, under a national coverage determination set in May, links coverage to the FDA-approved indication, which did not include transapical until Oct. 19. (See Also see "CMS Policy Sets Boundaries On Transcatheter Valve Procedure" - Medtech Insight, 7 May, 2012..)

“The delay of both the approval of cohort A and the clinical protocols that would have allowed reimbursement for this sizable group of patients reduced procedures,” Mussallem explained.

Had approval come sooner, the company estimates it could have received $3 million to $5 million in transapical access sales during the third quarter.

Also, the 2011 European launch of the company’s larger 29 mm, next-generation Sapien XT valve resulted in a transfemoral unit growth rate of more than 30% and stimulated transfemoral share gains, Edwards said.

“At the same time, non-transfemoral units declined approximately 20%, likely driven by heart teams more broadly adopting a transfemoral-first approach and some volume migrating to the new 29-millimeter transfemoral offering,” Mussallem said.

The company has also lowered its full-year transcatheter valve sales projections due to some of the market challenges it has experienced, even though Edwards says it expects a strong rebound in the fourth quarter resulting in a full-year underlying growth rate of approximately 70%.

“The delay of both the approval of cohort A and the clinical protocols that would have allowed reimbursement for this sizable group of patients reduced procedures” – Edwards CEO Michael Mussallem

“We expect a strong close to the year,” Mussallem stated.

Edwards calls current Medicare reimbursement rates for the Sapien procedure “fair” for hospitals. “We are very pleased with the overall progress of the U.S. launch. An impressive list of leading heart centers has enthusiastically adopted our Sapien technology, and overall procedural success rates remain very high,” Mussallem said.

Wells Fargo analyst Larry Biegelsen agreed that the approval of Sapien in cohort A “will likely reinvigorate U.S. Sapien sales in Q4 and beyond.”

Pipeline Updates

Edwards also said during the call that its efforts remain on track for its core pipeline products in the heart valve space.

In particular, enrollment is expected to end for its PARTNER II pivotal trial, for its next-generation Sapien XT transcatheter valve, in mid-2013.

Meanwhile, enrollment is under way in the European study of Edwards’ repositionable, self-expanding Centera valve, and the company continues to expect enrollment to begin by year-end in a study of its balloon-expandable Sapien 3 valve.

Sapien 3 is a lower-profile balloon expandable valve designed to further reduce paravalvular leak, while Centera is a low profile, repositionable self-expanding valve with a motorized delivery system for stable deployment and single-operator use, the company explained.

Further, initial results of the firm’s European PROTAVI trial evaluating its Embrella aortic filter device to protect against stroke following transcatheter valve procedures are expected to become available by the end of the year, the company reported.

In the surgical heart valve space, Edwards plans to complete enrollment in its CADENCE MIS and FOUNDATION clinical trials studying the minimally invasive surgical Edwards Intuity aortic heart valve replacement system by March of next year. Edwards Intuity, designed to facilitate rapid valve deployment as well as a smaller incision and fewer sutures compared to conventional heart valve surgery, launched in Europe in February. (See Also see "New Products In Brief" - Medtech Insight, 27 February, 2012..)

During the third quarter, Edwards also completed enrollment in its TRITON CE mark trial for the next-generation Edwards Intuity system, which features enhancements to both the delivery system and the valve.

Edwards Reveals Sapien Launch Plans For Transapical Delivery Method

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