St. Jude Medical

2014 med tech R&D budget: $692 million
Change from 2013 budget ($691 million): 0.1%
Percent of 2014 segment sales ($5.62 billion): 12.3%

At more than 12% of sales, St. Jude's ($STJ) R&D spending was quite high compared to its peers. That's down slightly from its peak of $705 million in 2011, but well above 2010's expenditure of $631 million.

The biggest issue facing its pipeline is the fate of its Portico TAVR in the U.S., where it seeks to join Medtronic ($MDT) and Edwards Lifesciences ($EW) as a provider of artificial heart valves to patients too frail for open-heart surgery.

The device suffered a rare withdrawal of its CE mark after a safety scare involving reduced leaflet mobility, but it appears the problem is not dangerous and was an artifact of advanced imaging techniques, which spotted an abnormality that actually occurs in many cardiology implants.

Portico is back on the market in Europe and recently received the go-ahead from the FDA to resume its pivotal trial in the U.S. for approval in the company's home country.

In addition, St. Jude is awaiting word from the FDA regarding the PMA application of the Axium Neurostimulator System to treat chronic pain. It purchased manufacturer Spinal Modulation for $215 million in April. A decision is expected by the end of the year.

St. Jude is also testing the pediatric Masters HP Series mechanical heart valve. At 15 mm, the company hopes it will become the smallest device of its kind on the market, but the FDA will have the final say.

Hypertension-lowering renal denervation is another priority, in spite of widespread skepticism following a flopped Medtronic trial that set the whole field back.

"We will not say more at this time for competitive reasons, but investors should know that we are continuing to move forward with planning our confidential research and development and with clinical trials in the area of renal denervation for treatment resistant hypertension," St. Jude CEO Daniel Starks said during the company's Q2 2014 earnings call in July.

Recent approvals include patient heart monitor CardioMEMS, which the company acquired upon FDA approval in May 2014, and FlexAbility Ablation Catheter, used by electrophysiologists in the treatment of cardiac arrhythmias. -- Varun Saxena (email | Twitter)

For more:
St. Jude gains CE mark for first app-based pain neuromodulation patient trial system for use ahead of implant
St. Jude Medical gets FDA OK to resume trial of Portico TAVR
Issue that led to halt of St. Jude TAVR trial no cause for concern, EuroPCR experts say
St. Jude says alternative imaging system is optimal during stenting procedures
St. Jude aims for Axium approval before year-end, with robust neuromodulation growth in 2016

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