Tag Archives: Interventional Cardiology

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Results of St. Jude Medical's RESPECT Trial Published in The New England Journal of Medicine

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By Business Wirevia The Motley Fool

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Results of St. Jude Medical’s RESPECT Trial Published in The NewEngland Journal of Medicine

Eight-year study confirms PFO closure was superior to medical therapy alone in reducing risk of recurrent stroke in prespecified per-protocol and as-treated cohorts

ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced publication of results from its landmark RESPECT trial in The New England Journal of Medicine. The study results show that device closure using the AMPLATZER™ PFO Occluder is superior to antiplatelet medications or warfarin in preventing recurrent cryptogenic stroke (a stroke from an unknown cause) in patients with a common heart defect called a patent foramen ovale (PFO), as measured in the prespecified per-protocol and as-treated patient cohorts of the trial. Patients in the study had a 51 to 73 percent risk reduction in recurrent strokes when evaluated across prespecified measures.

Photo of AMPLATZER PFO Occluder. (Photo: St. Jude Medical, Inc.)

Normal in a developing fetus, the foramen ovale allows oxygenated blood from the placenta to bypass the lungs. This small, flap-like opening typically closes shortly after birth. When this flap remains open, or patent, it is referred to as a PFO. A PFO can potentially allow dangerous clots to pass from the right side of the heart to the left, travel up to the brain and cause a stroke. Studies show that nearly half of all people who suffer a cryptogenic stroke also have a PFO.

“The results of this landmark study are clinically important as we continue to search for solutions for young and middle-aged patients with a long-life expectancy, who are at risk of having a second stroke. The RESPECT trial data shows device closure with the AMPLATZER PFO Occluder, in carefully selected patients, is quite safe, effective in closing the PFO, and lowers the risk of recurrent stroke in two of the three patient cohorts,” said Dr. John D. Carroll, director of the Cardiac and Vascular Center and Interventional Cardiology at the University of Colorado Hospital and lead author of the journal article. “The reduction in stroke achieved in the PFO-closure group exceeds that of several well-established pharmacologic treatments for the prevention of secondary strokes.”

Conducted over the course of eight years at 69 medical centers in the U.S. and Canada, the RESPECT study followed 980 participants who had suffered a cryptogenic stroke that was confirmed by stroke neurologists using routine imaging technologies. The average age of the …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Boston Scientific vs. St. Jude: Is Either Stock Worth a Buy?

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By Dan Carroll, The Motley Fool

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You wouldn’t know that medical device makers Boston Scientific and St. Jude Medical are having a tough time by checking out their stock charts alone. Boston Scientific‘s hovering near a 52-week high after pulling in gains of nearly 28% to start 2013; St. Jude has also done well, racking up more than 17% year-to-date. But short-term gains can be deceiving, and both companies’ recent financial struggles have kept investors awake at night.

There’s always hope for beaten-down companies looking to turn things around, however. Today, we pit Boston Scientific and St. Jude head-to-head to see which company — if either — is worth your investment.

Boston Scientific: Escaping the CRM market
It’s no secret that Boston Scientific‘s been struggling financially lately. The company’s revenue fell nearly 5% year-over-year in 2012, although it did manage to slow its decline in its most recent quarter. The company’s top two divisions by sales, Interventional Cardiology and Cardiac Rhythm Management (CRM), have led things lower.

The CRM market‘s stagnation has crushed every company involved, from Boston Scientific to the largest companies in the medical device market, such as rival Medtronic . Boston Scientific‘s taken a particularly tough blow, however: While Medtronic’s CRM sales have only lost 3% over the past nine months, Boston’s took a crushing 7% blow in 2012. The company needs to move away from this field in the future in order to succeed, as the CRM market has already matured in advanced economies and won’t see much future growth for a while.

Unfortunately, CRM sales make up 26% of Boston Scientific‘s total revenue right now. Interventional Cardiology sales, which fell more than 14% last year, make up another 30% of the total; in all, Boston Scientific‘s exposed to revenue black holes for more than half of its sales. That won’t impress growth investors.

However, the company has been making small but important steps to diversify into higher-growth fields. Boston Scientific‘s inroads into the stent market should appeal to long-term investor. Stents have become a promising field, and Boston Scientific‘s Promus line has ranked among the top-selling drug-eluting stents alongside Medtronic’s Resolute and the clear market leader in Abbott‘s Xience. Boston Scientific also has a next-generation bioabsorbable stent in development, the Synergy, which has already received CE Mark approval. It’s not quite as revolutionary as Abbott’s next-gen fully dissolving Absorb stent, but it’s enough to ensure Boston’s competitiveness in the industry going forward.

The company’s neuromodulation unit has also shown impressive growth despite its small size — it only makes up around 5% of the company’s total sales — but are these glimmers of hope enough to beat St. Jude?

St. Jude: Beating back the woes
St. Jude isn’t immune to the CRM market‘s woes; if anything it’s in an even worse position than Boston Scientific. Nearly 52% of the company’s total sales came from its CRM business in 2012, and with sales falling 6%, that’s not a statistic that …read more
Source: FULL ARTICLE at DailyFinance