Edwards valve stumble makes Tiara sparkle

With transcatheter aortic valve implantation (TAVI) now an established technique and a maturing market, attention has shifted to the harder-to-reach valves, with the mitral valve next in line. Yesterday Edwards Lifesciences, leader of the TAVI market, revealed that its dedicated mitral device had hit a snag, and the much smaller company Neovasc could be the beneficiary.

Edwards has halted enrolment into the first human trial of its Fortis valve after reports of thrombosis, and Neovasc’s Tiara is the next most advanced transcatheter mitral valve in the clinic. Edwards’ shares fell 4% in early trading yesterday but had recovered by the end of the day; Neovasc closed up 11%. The race is on.

Fortis in arduis

Edwards has so far treated more than 20 patients with the Fortis valve, all of whom had symptomatic mitral regurgitation. The company said it had anticipated that optimising the valve would prove challenging, but it intends to stick with it after investigating the thrombosis cases. It did not say how many patients were affected, or how many are to be enrolled in the trial in total.

The company’s development path for Fortis is expected to run along similar lines to that for its highly successful Sapien aortic valve, with the company seeking approval in the very sickest patients first – those who do not have the option of valve replacement via open surgery – and then expanding into less ill populations.

A later-generation version of Sapien, Sapien XT, is CE marked in Europe for use in the mitral position, including in valve-in-valve procedures, where a transcatheter device is deployed within an already implanted surgical valve. Edwards has said that this is not a large financial opportunity. The real prize remains approval for a dedicated mitral product.

As is usual in medtech, Edwards will seek European approval first: the Fortis trial is Europe-based and no US-based clinical activity is registered on clinicaltrials.gov.

Neovasc, however, is already treating US patients in its first human clinical trial, Tiara-I, which also includes a European site. In March, when five patients had received implants, analysts at Leerink described Tiara as being at the forefront of the mitral market.


Also in the running is the private group Tendyne, which implanted its first mitral valve in a patient in a US clinical trial in April, and CardiAQ Valve Technologies, which, also in April, received the FDA’s approval to start a clinical trial of its mitral valve; it has also implanted four patients in Europe.

Tendyne’s valve is called Tendyne, and its trial is called Tendyne too; perhaps it is not the most imaginative of companies. CardiAQ has two products, called the CardiAQ transfemoral and transapical systems. 

This is a rare spot in interventional cardiology in which Medtronic has shown little interest. The company is in second place in TAVI but its mitral device is yet to move out of animal studies.

The products are at an early stage, and this is very much a David and Goliath situation; with Edwards vastly larger than any of the other players it will have the cash to conduct large-scale clinical trials – if Fortis is good enough to be worth the investment.

And there is of course the other obvious scenario: if Edwards cannot resolve its Fortis thrombosis proble it might choose to bring in one of the other up-and-coming devices via an acquisition. Edwards is one of the least acquisitive companies in medtech, having made only three purchases in the past decade; it may have to change its habits if Fortis cannot be salvaged.

Company Device Trial name Trial description Trial ID
Edwards Lifesciences Fortis - European, 20 implants confirmed, full enrollment and completion date unknown -
Neovasc Tiara Tiara-I US and European, 30 patients, five implants confirmed, primary completion date December 2015 NCT02276547
Tendyne Tendyne Tendyne US and Australian, 30 patients, one implant confirmed, primary completion date July 2015 NCT02321514
CardiAQ Valve Technologies CardiAQ transfemoral and transapical - US, 20 patients, one implant confirmed, completion date unknown -

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

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