World Heart gets FDA approval to reduce size, revise Reliant trial

By Elaine Rigoli

Tampa, Fla., April 24 - World Heart Corp. announced Monday that the Food and Drug Administration has given conditional approval of the company's Investigational Device Exemption supplement for modifications to the Reliant clinical trial design.

These trial revisions reflect advances in the field of mechanical circulatory support, allowing the company to expand the trial to a broader group of patients more quickly, officials said.

According to a company news release, the trial design changes include:

• Sample size reduction, to 208 from 390 patients, expected to significantly reduce the time required to complete the trial. The Reliant destination therapy (DT) trial has already enrolled nearly 20% of the newly required number;

• Broadened patient inclusion criteria and reduced waiting times for high-risk patients;

• A new group of potential patients, allowing elective implantation of the Novacor Left Ventricular Assist System in commercial DT patients needing replacement of competitor Thoratec Corp.'s pump.

Based in Oakland, Calif., World Heart develops mechanical circulatory support products and services.

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