News Feature | February 6, 2017

Edwards Lifesciences Preps Clinical Trials As TAVR Drives Sales

By Jof Enriquez,
Follow me on Twitter @jofenriq

edwards HQ sign

Edwards Lifesciences reports that increased uptake of transcatheter heart valves drove up fourth quarter sales by 14 percent, to $768 million. The company expects to implant more of said devices with the ongoing PARTNER III study, and the initiation of EARLY-TAVR trial, which will include patients diagnosed with severe aortic stenosis who have not yet developed symptoms.

Global Transcatheter Heart Valve Therapy (THVT) sales rose 29 percent to $432 million, while U.S. THVT sales grew 38 percent, according to a news release. Edwards says surgeons now are implanting the company’s SAPIEN 3 TAVR devices at more than 500 hospitals in the U.S.

"We ended the quarter with underlying sales growth of 15 percent, driven by strong adoption of transcatheter aortic valve replacement (TAVR) therapy, and finished the year with global sales of nearly $3 billion," said Edwards CEO Michael A. Mussallem.

The increased implantation rates of SAPIEN 3, along with limited mitral heart valve supply, impacted Surgical Heart Valve Therapy sales, which was down 3.5 percent for the quarter at $189.4 million. Critical Care sales were up 4.1 percent to $146.3 million, lifted by the Enhanced Surgical Recovery Program in the U.S. and developing markets.

Edwards estimates the global TAVR market to be worth as much as $5 billion by 2021, and is trying to hold off competitors like Boston Scientific, Direct Flow Medical, and St. Jude Medical. Edwards has been steadily shoring up its leadership position in the TAVR space in 2016, punctuated by expanded indications for its SAPIEN 3 and SAPIEN XT transcatheter heart valves in intermediate-risk patients suffering from aortic valve stenosis.

The company said last month that it is investing aggressively in the research and development of “transformational” therapies, and is planning several clinical trials in 2017.

Edwards last year received FDA approval for the PARTNER III Trial to implant the SAPIEN 3 in 1,300 low-risk, elderly patients, suffering from severe, symptomatic aortic stenosis, and company executives expect this randomized trial to be fully enrolled this year.

The upcoming EARLY-TAVR Trial, which was just approved by FDA, will evaluate patients diagnosed with severe aortic stenosis who have not yet developed symptoms. The company will enroll 1,000 patients in 65 cardiovascular centers later this year. This IDE study will randomize patients to receive either transfemoral TAVR with the SAPIEN 3 valve or clinical surveillance.

"We're engaged in wanting to study this group of patients that have not yet demonstrated symptoms. We're firm believers that people with severe aortic stenosis are really at risk and we're prepared to do the clinical study to test that. We won't get our results for a while, of course, but we think it could be very meaningful once you get out into the future, probably beyond 2021," Mussallem told analysts, according to a Seeking Alpha call transcript.

Mussallem says Edwards is in the process of integrating newly-acquired Valtech Cardio, developer of the Cardioband System for transcatheter repair of mitral and tricuspid valves. The mitral application of Cardioband has received a CE Mark in Europe, and an IDE study in the U.S. is expected to begin enrollment later this year.

The paused CardiAQ program for transcatheter mitral replacement via transseptal delivery will resume enrollment in the second quarter, pending positive results of further design validation testing on one of the valve’s features.

Mussallem believes Edwards' strong growth and progress last year will carry over into 2017, especially as the company "bring[s] big powerful studies that are highly scientific to bear..."

"We are enthusiastic about the continued expansion of transcatheter-based therapies for the many structural heart patients still in need, which positions us for long-term success. We believe our patient-focused innovation strategy can transform care and bring value to both healthcare systems and shareholders," he said.