Boston Scientific Corporation (BSX) announced positive results from the Reprise I feasibility trial at the Euro PCR in Paris. The study evaluated the safety of the Lotus valve system, a transcatheter aortic valve replacement (‘TAVR’) device, in patients with severe aortic valve disease.
In April 2012, enrollment (of 11 patients at 3 sites in Australia) was completed in the Reprise I clinical trial. Successful implantation of the device without in-hospital major adverse cardiovascular or cerebrovascular events (:MACCE) through discharge or seven days post-procedure (whichever comes first) was the primary endpoint. The selected patients had severe symptomatic aortic stenosis and were considered at high risk for surgical valve replacement. No in-hospital MACCE (in 91% of the patients) or mortality was observed. However, one patient suffered a stroke. No moderate or severe paravalvular regurgitation was present after valve placement or at discharge.
The Lotus valve came to be included in the portfolio of Boston Scientific following the acquisition of Sadra Medical in 2011. During the third quarter of 2012, the company plans to enroll another batch of 120 patients at up to 15 sites in Australia and Europe in the Reprise II study, scheduled to be completed in the first half of 2013. The Reprise II study will evaluate the safety and performance of the Lotus valve, data from which will be used to support CE Mark regulatory approval, anticipated in the second half of 2013.
Boston Scientific also announced data from the Evolve trial. It was observed that the Synergy stent was non-inferior in treating de novo coronary artery lesions at one year compared to Promus Element. The trial reported one-year clinical and six-month intravascular ultrasound (:IVUS) outcomes data, evaluating the safety and effectiveness of the Synergy stent.
Despite the innumerable headwinds in its core segments of stents and defibrillators, Boston Scientific is working on portfolio expansion. Other players in the medical devices space, such as Medtronic (MDT) and St Jude Medical (STJ), are also engaging in various alternatives to revive their flagging top line. Successful commercialization of the new technologies is expected to boost the company’s top line in the forthcoming period.
We have a Neutral recommendation on Boston Scientific. The stock retains a Zacks #3 Rank (hold) in the short term.
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