BSX Initiates Ingevity Trial

Boston Scientific Corporation ( BSX - Analyst Report ) recently commenced a trial for its next-generation Ingevity pacing leads. The first patient was implanted to evaluate the safety, effectiveness and performance of the leads.

Pacing leads are insulated wires to treat bradycardia by connecting the implantable pacemaker to the patient’s heart. Bradycardia is a condition, where the heart beats too slowly and curbs oxygen supply to the body. In order to maintain the required heart rate for a physical activity, pacemakers and leads work together to stimulate the heart rate, thereby avoiding oxygen deficiency in the body.

The trial will establish whether Ingevity pacing leads are superior to standard leads currently available. The performance will be assessed on the basis of adjustability, reliability, fixation and electrical performance of Ingevity.

Also worth mentioning in this context is the ability of Ingevity leads to function in a magnetic resonance imaging (MRI) environment. This could present an advantage over standard leads as many patients with pacemakers are barred from undergoing an MRI scan, as powerful magnets used in MRI scans may interfere with pacemaker functionality.

The non-randomized study will be used by Boston Scientific to support the regulatory filing of Ingevity in the U.S. and the EU.

Boston Scientific is also looking to study Ingevity leads with its Ingenio pacemakers. The company plans to initiate a study in the first half of 2013 to assess the performance of the Ingevity-Ingenio combination in MRI scans. Results from this study will be used to seek FDA approval for using Boston Scientific’s Ingevity and Ingenio in conjunction.

Acknowledging the challenges at play in its core segments, Boston Scientific is focusing on strategic initiatives like portfolio expansion, restructuring initiatives, emerging markets and share buyback programs. With the dismal performance of the company’s Cardiac Rhythm Management (CRM) line, product approvals in latent areas should help reduce the impact of the sluggish CRM market. A similar strategy is also being followed by its peers, St. Jude Medical ( STJ - Analyst Report ) and Medtronic ( MDT - Analyst Report ) .

We currently have a long-term ‘Neutral’ recommendation on Boston Scientific, which carries a short-term Zacks #3 Rank (Hold). Its peer Johnson & Johnson ( JNJ - Analyst Report ) carries a Zacks #2 Rank (Buy).