Boston Scientific Corporation (BSX) has received approval from the US Food and Drug Administration (FDA) for additional indications for its cardiac resynchronization therapy defibrillators (CRT-Ds). Following this approval, Boston Scientifics’ CRT-Ds are the only devices to treat all patients under four classes of heart failure as per New York Heart Association (NYHA). 

Earlier, Boston Scientific’s CRT-Ds were approved for two classes of patients – III and IV. Subsequent to the approval, the CRT-Ds will be implanted in patients with Left Bundle Branch Block (LBBB). 

The expanded approval is based on favorable data from the MADIT-CRT trial, with more than 1,800 patients, which demonstrated that CRT-Ds reduce death and heart failure events. About 70% of the patient population of the trial was with LBBB. Under a request from the FDA, further analysis of trial data was done. It was observed that patients with LBBB who received CRT-D therapy had a 57% lower risk of death or heart failure compared with patients who received only implantable cardioverter defibrillator (ICD).

Additional indications for Boston Scientific’s CRT-Ds will increase the targeted patient population, thereby improving its top line. This is important since the company’s Cardiac Rhythm Management (CRM) has been suffering due to shipments of defibrillators being stalled. The company had to suspend sales of its defibrillators after it failed to alert the US Food and Drug Administration (FDA) regarding changes in the manufacturing process of these devices.

However, the resumption of CRT-Ds and ICDs sales helped the company to prevent erosion of its top line and market share during the latest reported quarter. On the international front, international ICD business benefited from the launch of the Teligen ICD and Cognis CRT-D in Japan. We are also pleased to note that Boston Scientific expects an impact of $44 million in the next two quarters from the product recall, lower than the earlier expectation of $55 million per quarter. Further, the company expects ICD market share to increase slightly from 24% to 25%. 

 
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