Medical Device Daily

Initial results from the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) are proving to be more than just a shining endorsement for the use of these applications. In the few days since the report came out, companies occupying the market space for CRT-D devices have seen significant gains in their stock prices.

Boston Scientific (Natick, Massachusetts), the company that sponsored MADIT-CRT, and St. Jude Medical (St. Paul, Minnesota) are expected to have the largest benefit from the study results – as the two med-tech companies occupy the most CRT-D market space. Medtronic (Minneapolis) also saw impressive gains.

"While a rising tide will likely float all boats, and the news is positive for Boston Sci, Medtronic, and St. Jude Medical – we note that as a Boston Scientific-sponsored study there should be a run-off benefit for Boston Sci and as St. Jude has the largest exposure to ICDs it should have the most meaningful revenue benefit (STJ's 35% versus BSI's 21% and MDT's 20%)," said BMO Capital Markets (New York) med-tech analyst Joanne Wuensch in a research note.

Wuensch added that this is the first positive clinical trial for the ICD industry in five years, and the study is expected to help expand the patient pool as physicians look to intervene earlier in NYHA Class I and II patients to stop the natural progression of hart failure.

In addition to increased market penetration, market growth should be further aided by the higher ASP CRT-D devices, she said. "Estimates range for an increase in the market's growth rate from 1%-2% to 2% to 4% in a worldwide market we expect will increase 4.7% in 2009."

"We're very encouraged by the initial results," Annette Ruzicka, director of media relations for Boston Scientific, told Medical Device Daily. "I think it was positive for the patients and for all three of the major players in the field."

The company's CRT-D, Cognis, stands to gain significant attention once the study is completed. Cognis was granted FDA approval in mid-May.

St. Jude's portfolio of CRT-D applications also stands to gain more attention and includes; Promote Plus – a cardiac resynchronization therapy defibrillator (CRT-D) that offers alert features for atrial tachycardia and atrial fibrillation, and Promote Accel CRT-D – a CRT-D device designed to tailor treatment to each patient's unique needs, including features such as AT/AF alerts and three chamber capture confirmation (approved for use in Europe only).

Until the study is complete, many companies still remain have a level of anticipation, noting that the entire story has yet to be told.

"I think what happens now is that we wait for the final results of the study to be published, which we'll probably see later this year," Ruzicka said. "Then at the end of the year depending on what the study reveals [Boston Scientific] will ask the FDA for an expansion for Cognis serve Class 1 and Class 2 patients suffering from heart failure."

Stronger data means stronger ammunition to bring to the FDA to build a stronger case for the expansion of the product, she said.

More than 1,800 patients were involved in the trial, with findings that show there is a 29% reduction in heart failure or death in those with heart disease who received an implanted cardiac resynchronization therapy device with defibrillator (CRT-D) versus those who received only an implanted cardiac defibrillator (ICD-only). The trial followed the patients for up to 4-1/2 years.

"The MADIT-CRT trial has shown that if intervention is conducted early enough, the outcome for the patient will be better over time," said Mark Carlson, MD, chief medical officer of the Cardiac Rhythm Management Division of St. Jude Medical in an e-mailed statement to MDD. "The next step for our industry is to ensure physicians and patients are aware of the clinically proven effectiveness of this treatment and that they benefit from the currently available cardiac resynchronization therapies."

Cardiac resynchronization therapy is used to treat the symptoms and complications associated with certain types of heart failure (HF). CRT is administered using a pacemaker, called a CRT-P, or an ICD with pacing capabilities, called a CRT-D.

A CRT-D has the added ability to defibrillate the heart if a patient is at risk for life-threatening arrhythmias. CRT stimulates both of the heart's lower chambers so that they are "synchronized" and more efficient in pumping blood to the body. The stimulation takes place via a pulse generator (the ICD or pacemaker) and pacing leads, which are placed next to the heart's tissue and deliver electrical impulses to the heart.

CRT-D devices are priced about 10% to 20% above traditional ICDs, carrying an estimated $30,000 price tag.