MedCity Influencers

Boston Scientific nears a win with cardiac defibrillators

A Food & Drug Administration panel is set to decide whether Boston Scientific Corp. (NYSE:BSX) […]

A Food & Drug Administration panel is set to decide whether Boston Scientific Corp. (NYSE:BSX) can sell its cardiac resynchronization therapy defibrillators to patients suffering from milder forms of heart failure, setting the stage for a big win for a company that’s badly in need of positive news.

BSX goes before the the FDA’s circulatory systems devices panel March 18 in College Park, Md., to press its case for the expanded indication. The panel will decide if the company provided enough evidence to convince regulators that the devices are effective in treating all types of heart failure.

Boston Scientific’s current indication is for patients diagnosed with New York Heart Assn. Class III or Class IV heart failure, classified as the most severe cases.

A green light from the feds could have a positive impact on the company’s sales, essentially opening up the entire patient pool of about 4.6 million Americans suffering from heart failure, as estimated by the Heart Failure Society of America. In the European Union, about 14 million patients suffer from heart failure, according to the European Society of Cardiology, putting the potential worldwide market at nearly 20 million patients.

The expanded indication could help mitigate some of the damage BSX has suffered over the past six months on Wall Street, where share prices have dropped by 34 percent since Sept. 1, 2009.

The latest embarrassment for the company: An announcement today that it is stopping shipments and retrieving the field inventory of all its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a paperwork problem with the FDA. That snafu set shares back another 13 percent, and it’s only the latest in a series of unfortunate incidents in the past two months, including thousands of layoffs and a massive, $1.7 billion settlement with Johnson & Johnson (NYSE:JNJ) to end a stent patents beef.

An expanded indication for the CRT-D business seems likely enough. In September 2009, the Natick, Mass.-based device giant was buoyed by a study published in the New England Journal of Medicine showing that the devices reduced the risk of heart failure in 41 percent of patients enrolled in the trial, significantly improved the heart’s pumping efficiency (but did not improving the risk of death).

The MADIT-CRT trial, which examined 1,820 patients with ischemic or non-ischemic cardiomyopathy over four-and-one-half years, compared treatment with an ICD alone with a CRT-D device.

Standard ICDs use two electrical leads to regulate the function of the right ventricle. CRT-Ds use a third lead to regulate the left ventricle as well.

After an average of 2.4 years, about 17 percent of the patients implanted with a CRT-D died or suffered a non-fatal cardiac event, compared with about 25 percent of patients in the ICD-only group.

But the overall risk of death was the same for both groups, although it was relatively low for each — about 3 percent annually.

At the time, Dr. Arthur Moss, principal investigator in the study, said he believes more doctors will start using the more expensive technology.

“I think there will be a progressive avalanche [of increased use] because heart failure societies have been very frustrated in the last four or five years at having no new drugs for heart failure,” Moss said.

The price tag for CRT-D devices tops out at about $35,000, up to $8,000 more than standard ICDs. The company’s CRM division posted an overall 5 percent bump in sales during 2009, topping out at about 2.5 billion.


MassDevice Staff

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.

Shares0
Shares0