When You're Committed to Clinical Excellence, It Makes More Possible.

Boston Scientific has been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.

In fact, more than 80% of U.S. patients who receive an ICD or CRT-D were first indicated for this therapy by a landmark Boston Scientific-sponsored clinical trial.*

First Indications Due to Boston Scientific Sponsored Clinical Trials*
	Heart Failure / CRT
	CRT-D devices first received FDA approval based on the CONTAK CD trial (2002). The COMPANION trial (2004) was the first to expand CRT-D to a primary prevention population. 100% of CRT-D patients were first indicated on the basis of one of these two trials.
	Secondary
	For patients with a history of ventricular arrhythmias, approvals were based on the first defibrillator trial (1985) and later expanded with MADIT (1996) to post-MI patients with EF ≤ 35% and inducible VT. 100% of patients who currently meet a secondary prevention indication were first indicated on the basis of one of these two trials.
	Primary Prevention (Ischemic, EF ≤ 30%)
	For patients at risk of ventricular arrhythmias, approval for ischemic patients with EF ≤ 30% but without prior inducibility was first received as a result of the MADIT II trial (2002). Patients meeting the MADIT II criteria make up 42% of the primary prevention indication population.
First Indications Due to Other Clinical Trials
	Primary Prevention (Ischemic, EF > 30%, and nonischemic)
	The remaining 58% of the primary prevention indication population was first indicated for ICD therapy based on the SCD-HeFT trial **, which extended ICD therapy to patients with a non-ischemic etiology and to patients with an ischemic etiology with an EF between 30–35%.

* ICD and CRT-D implant estimates using full-year 2007 data as of 8/08/08, including Boston Scientific CRM implant data, third-party implant data, and publically available industry information including analyst calls and earnings releases. Data on file at Boston Scientific. All calculations include indicated, on-label uses only. Primary prevention: First indication calculation for MADIT II (2002) assumes ischemic primary prevention patients with EF < 30%. Available data suggest 58% of primary prevention patients are ischemic and 71% of those patients have an EF < 30%. Of the primary prevention implants, 42% were first indicated by MADIT II. Secondary prevention: Of these total implants, 100% were first indicated by either MADIT (1996) or the trial that led to approval of the first defibrillator (1985) [Mirowski M, Mower MM, Veltri EP, Juanteguy JM, Reid PR: Recent clinical experience with the automatic implantable cardioverter defibrillator. Cardiol Clin 1985;3(4):623-30]. Heart failure: Of these CRT-D implants, 100% were first indicated by either COMPANION (2004) or CONTAK CD (2002). **sponsored by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH), Wyeth-Ayerst, and Medtronic.