are Edwards Lifesciences Inc. and Medtronic Inc. Though Edwards was first to market in
the United States, Medtronic has been working to make up ground, and the two heavyweights have duked it out in what many analysts predict is a $3 billion global TAVR marketplace. The firms also have taken their battle to courtrooms internationally.
Edwards launched its Sapien valve in the European market in 2007. Approval by the
U.S. Food and Drug Administration (FDA) came in 2011 for implantation using the transfemoral route. In 2012, the agency approved widened approval to those eligible for surgery
(though still high risk) and use of the transapical route of entry. Sapien is a balloon-ex-panded device built on a stainless steel frame, and the three leaflets are made from tissue
found in the outer wall of the cow heart (bovine pericardium).
Medtronic’s CoreValve device also was given CE mark in 2007, but Edwards didn’t have
any competition in the U.S. market until January of this year when CoreValve received
FDA approval. Like Sapien, CoreValve was approved for patients too frail to undergo traditional open-heart valve replacement. Notably, the Medtronic device was given the green
light by the agency without the input of an independent device advisory panel, which
usually is customary. In late 2013, the FDA announced it would not require an advisory
committee to weigh in on whether the data supported approval, noting that data from
the extreme-risk cohort of Medtronic’s clinical trial would be sufficient. CoreValve, which
is a self-expanding device made of a nickel-titanium frame with a tri-leaflet valve created
from porcine pericardium (derived from pig heart tissue), can be implanted via the femoral
artery, subclavian or by direct aortic access. Medtronic anticipates FDA approval of the
CoreValve System for high-risk patients sometime this summer.
Sapien and CoreValve come in a range of sizes, and both have had extremely solid
Data presented at this year’s American College of Cardiology (ACC) annual meeting
and simultaneously published in the New England Journal of Medicine showed that patient
results with CoreValve system were superior to surgical aortic valve replacement at one year
in patients at increased risk for surgery. It was the first time a prospective, randomized study
has shown any transcatheter aortic valve to be superior to surgery. Upon reviewing the CoreValve Trial’s results for high-risk patients, the FDA determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient
group without the need for an external expert panel. Thus is the rational behind Medtronic’s
anticipation of FDA approval of the CoreValve System for high-risk patients this summer.
Following the ACC meeting, analysts were bullish on Medtronic’s prospects.
Joanne Wuensch, an analyst with BMO Capital Markets told Medical Product Outsourcing she thinks that Medtronic will take a 25. 5 percent share of U.S. market by the end of
this year, 31. 8 percent in 2015, and 40 percent in 2016. This beats her firm’s previous estimates for 24. 8 percent, 24. 4 percent, and 30.2 percent, respectively.
“We leave ACC even more convinced that the company will take greater U.S. TAVR market
share from Edwards over the next 12-18 months than [Wall] Street expects,”Michael Weinstein,
a medtech market analyst with JPMorgan Chase & Co., wrote in a note to investors.
But Edwards has more up its sleeve. The company is engaged in a European clinical trial
comparing its lower-profile Sapien XT device against Medtronic’s CoreValve. The 241-pa-
tient trial revealed that 95.9 percent of the patients implanted with the balloon-expandable
Sapien XT device achieved device success compared to 77. 5 percent of patients confirming
the same for the self-expandable CoreValve arm.
Right now, Edwards has three versions of its Sapien line—Sapien, Sapien XT, and the
most recent design, Sapien 3, for which it has received investigational device exemption
(IDE) approval from the FDA to initiate a single-arm, non-randomized clinical trial in the
treatment of intermediate-risk patients with severe symptomatic aortic stenosis. The company also recently completed enrollment in its U.S. clinical trial studying the Sapien 3 valve
in the treatment of high-risk or inoperable patients.
Edwards received CE mark for Sapien 3 in January. The target U.S. approval date is
Custom Product Solutions
For Medical Device, Pharmaceutical,
and Rehabilitation OEMs
;Hot & Cold Therapy
COVIDIEN, COVIDIEN with logo, Covidien logo are U.S. and/or internationally
registered trademarks of Covidien AG. Other Brands are trademarks of a
©2014 Covidien. All rights reserved.
Covidien Quality Inside.
Custom Brand Outside.
Contact us at CPS@Covidien.com