Recently, medical devices major Boston Scientific Corporation (BSX) rounded off patient enrollment for the EVOLVE II trial, to evaluate its Synergy Stent System.
The company expected to complete enrollment by the third quarter of 2013. This is a breakthrough for the company to gain regulatory clearance from the U.S. Food and Drug Administration (:FDA) for the Synergy Stent System.
The EVOLVE II clinical trial is a randomized, controlled clinical trial to evaluate the efficacy and patient safety of the Synergy Stent System for the treatment of atherosclerotic coronary lesions. Not only will the results from the clinical study support Boston Scientific’s effort to obtain approval in the U.S., it will also back the company’s attempt to gain regulatory clearance in the high focus Japanese market.
The Synergy Stent System is already available in Europe as it gained the CE Mark approval in Oct 2012. Positive results from the erstwhile EVOLVE study fetched the CE Mark approval for the company.
Following clearance in Europe, Boston Scientific’s EVOLVE II trial commenced in Nov 2012. The study enrolled 1,684 patients at 125 sites across the globe. These sites are located in the U.S., Canada, Japan, Australia, New Zealand, Singapore and Europe. The enrolled patients will be observed for five years.
The principal investigator of the EVOLVE II study believes that the trial results will support the use of Synergy Stent System for optimal vessel healing. Built on market leading technology, the stent is perceived to be the most flexible, conformable and deliverable drug eluting stent (DES).
We believe that the DES market offers a promising growth opportunity for Boston Scientific. We note that revenues from the company’s DES business recorded a downfall in the last quarter. This was mainly due to softness in the U.S. market due to reduced market share from tough competition and pricing pressure across Europe.
We believe successful commercialization of the Synergy stent will enable Boston Scientific to strengthen its DES product portfolio. The commercialization of the Synergy Stent System should also lend some upside against competitive headwinds in the domestic market.
On the other hand, the DES business continued its robust performance in emerging markets. Management considers that DES business can offer the biggest opportunity in the emerging markets. The combined DES market is estimated at $700 million with a 20% growth rate. Evidently, Boston Scientific has several catalysts to tap the lucrative market opportunity in the DES space.
The stock currently carries a Zacks Rank #2 (Buy). Other Zacks Rank #2 medical stocks that warrant a look are Exactech Inc. (EXAC) and LeMaitre Vascular, Inc. (LMAT). We believe that Alere Inc. (ALR), carrying a Zacks Rank #1 (Strong Buy) is also worth considering.