Boston Scientific Reports Positive Clinical Trial Results For Its Lotus Valve System

Boston Scientific (NYSE:BSX) reported positive results for its Lotus Transcatheter Aortic Valve (TAVR) system through two studies- the REPRISE II Extended Cohort study and RESPOND Post-Market study- at EuroPCR 2015 held in Paris last week. The REPRISE II Extended Cohort study was an extension of the REPRISE II clinical trial that reported strong performance data at one year in September 2014. On the other hand, the RESPOND Post-Market Study was initiated in June 2014 to assess the performance and clinical outcomes of its Lotus TAVR in the treatment of patients with severe calcific aortic stenosis. The primary measures of outcome included all-cause mortality rates at 30 days and 1 year after the implant procedure. At the EuroPCR 2015 event, Boston Scientific reported positive thirty-day results for the first 250 patients in this study. This trial is expected to enroll a total of 1,000 patients by the end of its primary completion date (January 2017). ^[1] ((RESPOND Post Market Study, ClinicalTrials.gov, January 2014))

We have a price estimate of $15 for Boston Scientific, which is slightly below the current market price.

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Trial Results

The RESPOND Post-Market study indicated that less than 5% of the first 250 enrolled (out of a total of 1,000 planned enrollments) patients had mild leakage of a replaced transcatheter aortic valve (paravalvular aortic regurgitation (PVL)) and no patient exhibited moderate or severe PVL. As the absence of PVL commonly enhances long-term survival of the patient, the cardiovascular mortality rate was at 1.6%, which is equal to the rate exhibited by Medtronic’s CoreValve TAVR system in its latest CoreValve ADVANCE II study. ^[2]

The REPRISE II extended cohort 30-day study of 250 patients indicated that less that 14% of the patients had mild PVL and less that 1% had moderate PVL. The positive results from both studies reiterate the efficacy of TAVR therapy to replace impaired heart valves in patients who suffer from severe aortic valve stenosis and are too weak for traditional open heart surgery.

Market for TAVR

The LOTUS system is part of Boston Scientific’s Interventional Cardiology (IC) device offerings and has reported impressive growth in the international market since it received the CE mark in October 2013. Interventional Cardiology is the company’s largest division, representing approximately 30% of total sales. It derives its revenues mainly from coronary stents and catheters. In 2014, sales within this division grew 3% year-over-year to $2.05 billion, with the Lotus valve system growing by 31% year over year in the last quarter. ^[3]

Boston Scientific’s main competitors in the international TAVR market include Medtronic’s CoreValve TAVR system and Edwards Lifesciences’ Sapien Valve device. It is estimated that the global market for transcatheter aortic valves was $1.5 billion in 2014 with Edwards and Medtronic controlling approximately 65% and 31% of that market, respectively. ^[4] Currently, Boston Scientific’s share is less than 4% of the total market, according to our estimates. The positive clinical results are likely to help the LOTUS device gain further acceptance in the international market and should also boost its chances of entering the U.S. going forward.

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1. Post-Market Study Evaluating The Boston Scientific Lotus™ Valve System Demonstrates Extremely Low PVL Rates, News Releases, May 20 2015 [↩]
2. New, Old CoreValve Iterations Showing Reductions in Pacemaker Need, Paravalvular Leak, TCTMD.com, May 22 2015 [↩]
3. Boston Scientific’s (BSX) CEO Mike Mahoney on Q1 2015 Results – Earnings Call Transcript, Seeking Alpha, April 28 2015 [↩]
4. Edwards and Medtronic turn up TAVR competition with positive study data, Fierce Medical Devices, March 16 2015 [↩]