Medical devices major,
St. Jude Medical
) 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.
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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.
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.
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
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.