St. Jude's AVP4 Gets FDA Approval - Analyst Blog


Leading medical devices company, St. Jude Medical Inc. ( STJ ), has received the Food and Drug Administration's ("FDA") approval to launch its AMPLATZER Vascular Plug 4 ("AVP4") device in the U.S. The technology is used in minimally invasive transcatheter treatments to occlude abnormal vascular blood vessels to reduce pressure on the damaged vessels or reroute blood supply to malignant tumours.

With roughly 50,000 peripheral embolization procedures performed every year, St. Jude's Cardiovascular division is poised to considerably benefit from the new product, which is the first of its kind in the medical vascular products market.

Revenues from St. Jude's Cardiovascular segment moved up 3%, both in terms of reported and constant currency, to $336 million in the first quarter of fiscal 2012. Within the Cardiovascular segment, structural heart devices sales increased 8% to $155 million, partly offset by lower revenues from vascular offerings, which fell 2% year over year to $181 million.

The AVP4 is a unique device, which can access smaller and more difficult blood vessels and treat them with greater efficiency and precision than embolic coils and surgical clips. It also allows for better cross-sectional vessel coverage and can be flexibly maneuvered.

The AVP4 received CE Mark approval in July 2009. AVP and AVP II are the two other products from the AMPLATZER Family of Vascular Plugs available in the U.S.

St. Jude is consistently producing revenue growth and positive earnings surprises over the past several quarters. We are impressed by its solid fundamentals, healthy growth trajectory, strong product mix, robust pipeline and cost management initiatives.

While a host of new growth drivers (including new products and emerging markets) are expected to boost results in 2012 and beyond, we remain cautious about increased competition, a still soft Cardiac Rhythm Management ("CRM") market and the dilutive impact of acquisitions. 

A still choppy CRM space overhangs on St. Jude and its peers Medtronic ( MDT ) and Boston Scientific ( BSX ). Our long-term Neutral recommendation on St. Jude is in agreement with a short-term Zacks #3 Rank (Hold).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: BSX , MDT , STJ

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