Edwards Receives Approval For Sapien XT In Japan

Espicom View: With this Edwards Lifesciences continues to dominate the transcatheter aortic valve replacement market with its Sapien range of valves. Competition is heating up in Europe; however, Edwards Lifesciences has had its second-generation device approved in the region and is now working on the next-generation valve. The company is yet to have any competition in the US and it seems that competitors are lagging behind in Japan also. The increase in transcatheter aortic valve replacement procedures thank to new guidelines and Medicare coverage have secured growth for the Sapien range of valves. As Edwards Lifesciences is ahead of the game at this point in time, the company will continue to take market share in the medium-term. In the longer-term, with companies such as Medtronic, St Jude Medical and Boston Scientific bringing transcatheter aortic valve replacement systems to market, Edwards Lifesciences will have to share some of this lucrative market.

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Edwards Lifesciences' Sapien XT valve, making it the country's first commercially available transcatheter aortic heart valve. The company expects to obtain reimbursement approval from MHLW by year's end, and will initiate a full launch in Japan immediately thereafter.

In patients who are not good candidates for surgical aortic valve replacement, the Edwards Sapien XT valve can be implanted via a catheter into a beating heart. The device can be delivered through the transfemoral artery in the leg or transapically, through a small incision between the ribs. The valve's bovine pericardial tissue leaflets are based on Edwards' clinically proven surgical heart valves.

The Edwards Sapien XT valve has been studied in the treatment of thousands of patients in both commercial and clinical trial environments. The clinical study in Japan was conducted in Osaka University Hospital (Osaka), Sakakibara Heart Institute (Tokyo) and Kurashiki Central Hospital (Okayama). Additionally, the valve has been used widely by clinicians throughout Europe since its commercial launch in 2010. In the US, the Sapien XT valve is not commercially available; it is an investigational device being studied as part of a randomised, pivotal clinical trial. However, the original Sapien valve was approved in the US in November 2011.

In 2012, Edwards' total revenue increased, but while two of its segments remained stagnant, the Transcatheter Heart Valves segment experienced impressive growth. This is also reflected in first quarter 2013 sales. First quarter 2013 revenue from its Critical Care and Surgical Heart Valve Therapy units is declining and revenue from its Transcatheter Heart Valves unit is offsetting these losses. Medicare announced coverage for transcatheter aortic valve replacement (TAVR) procedures recently and this has provided growth for Edwards. The number of TAVR procedures in the US has increased following coverage and Edwards is the only company currently able to benefit from this. Competition is becoming fierce in Europe; although this has not swayed Edwards, it still is seeing impressive growth for its system in the region.

Edwards has dominated the market since it first launched the TAVR device. The company was the first to market in the US and Europe, and now it is the first to market in Japan. Edwards still has the only device that is approved in the US, but other companies are closing the gap. Medtronic acquired CoreValve in April 2009 and has since had its Engager system CE-marked in February 2013. In January 2011, Boston Scientific acquired Sadra Medical to boost its own heart valve portfolio; the company's Lotus heart valve entered clinical evaluation in October 2012. In addition, JenaValve, a Munich, Germany-based company, had its second-generation TAVR system CE-marked in October 2011, while St Jude Medical had its Portico transcatheter heart valve CE-marked in October 2012; however, this is a transfemoral system. These companies are yet to gain FDA or MHLW approval, therefore Edwards is still ahead of the game and is currently working on its next-generation valve, Sapien 3, which is currently in clinical trials. Medtronic is currently putting its CoreValve system through clinical trials in Japan, but Edwards will have the benefit of getting to market first.

This article is tagged to:
Sector: Medical Devices
Geography: Japan

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