Guidant projects the U.S. implantable defibrillator market will double to about $2.8 bil. as the applicable patient population expands based on indications evaluated in its recent MADIT II study. A related Guidant ICD PMA supplement was submitted in December 2001.

Despite the eligible U.S. population of 300,000 under current FDA-approved indications, only about 60,000 ICDs are implanted annually - a 20% penetration rate that makes up a roughly $1.4 bil. domestic market. However, the favorable results from MADIT II could double the ICD-eligible U.S. population to 600,000. "If we only get the penetration that we have now" with "one out of five patients...it becomes a $2.8 bil. market," CEO Ron Dollens told analysts at a Jan. 8 session of the JP Morgan H&Q health care conference in San Francisco.

Accordingly, Dollens expects the ICD market growth rate to accelerate from its current level in the low teens over the next several years. "We think MADIT II by itself will get it in the high teens growth if not in excess of 20%," the exec said. In 2002, Guidant expects its own ICD growth to be about $80-90 mil., without much of a reflection around MADIT II, Dollens commented. Current annualized Guidant ICD sales are in the $700 mil. range, analysts say.

The 1,232-patient MADIT II study was halted Nov. 20 by an independent data and safety monitoring board after finding a 30% mortality reduction when ICDs were used instead of drugs alone in heart attack survivors with moderate left ventricle impairment. The trial included 71 U.S. and five European centers (¹ Also see "Guidant MADIT II Trial Could Support Doubling Of ICD-Eligible Population" - Medtech Insight, 26 November, 2001., p. 30).

Separately, Guidant also is hoping to gain FDA approval for its Contak CD resynchronization therapy device sometime in April in order to regain ground lost to Medtronic with the August 2001 approval of the firm's InSync biventricular pacing system and a pending PMA for the ICD version.

The firm notes it has enrolled 279 patients at 27 centers out of a planned total of 1,042 patients as part of its DELIVER trial using its paclitaxel-coated Achieve stent. Enrollment is expected to be complete by the second quarter.

Guidant Expects Similar 20% Penetration Of Expanded ICD Market Via MADIT

More from Archive

More from Medtech Insight