CE Mark Approval for STJ's Assura

Medical devices major, St. Jude Medical ( STJ - Analyst Report ) recently won the European CE Mark approval for its line of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) named Assura. The three latest Assura devices available in Europe are Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.

The Assura product line gained the approval of the U.S. Food and Drug Administration in May 2012. The Assura devices from St. Jude Medical’s Cardiac Rhythm Management (CRM) division are already garnering revenues for the company in the domestic market. The CE Mark approval will position the portfolio to extract incremental revenues in the European market.

About Assura

The target for Assura product line are patients prone to sudden cardiac death (SCD) due to abnormally fast, potentially fatal cardiac rhythms and patients at risk of heart failure. The Assura ICDs and CRT-Ds address this problem and offer precise solutions.

Statistics from meta-analysis conducted by the Sudden Cardiac Arrest Thought Leadership Alliance (SCATLA) indicate that about 180,000-450,000 people are annually affected by sudden cardiac death in Europe. Hence, there is considerable scope for penetration in the European market.

The Assura portfolio will include advanced sensing options which can reduce the probability of untimely shocks. The new device comes with SecureSense RV Lead Noise Discrimination, CorVue congestion monitoring and expanded ShockGuard Technology.

The SecureSense RV Lead Noise Discrimination can identify lead related problems for improved patient safety. This algorithm distinguishes between lead noises and actual ventricular fibrillation or ventricular tachycardia that requires life saving treatment. This is possible due to reduced uncertainties associated with lead issues. The ShockGuard technology works on a parallel note by distinguishing between benign arrhythmias and rhythms that necessitate defibrillation therapy.

Our Take

We have a long-term ‘Neutral’ recommendation on St. Jude Medical which carries a short-term Zacks #3 Rank (Hold). While the company is battling pricing pressure and declining volumes in the domestic ICD market, it continues to have a substantial market share in the worldwide CRM market along with Boston Scientific ( BSX - Analyst Report ) and Medtronic ( MDT - Analyst Report ) .

With a slew of new products, the big three players in the ICD market are striving to gain market share, despite the challenging business environment and a sluggish CRM market. These players are also exploring new avenues of growth beyond the mature pacemaker and ICD markets. With gradual stability in the ICD market, these players should be able to revive their top line.