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WorldHeart LVAD Destination Therapy In Line At FDA Behind Thoratec

This article was originally published in The Gray Sheet

Executive Summary

WorldHeart will submit a PMA supplement in the third quarter seeking a destination therapy indication for its Novacor left-ventricular assist device

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WorldHeart

PMA supplement covering Novacor left ventricular assist system as an alternative to transplant for end-stage heart failure patients is submitted to FDA, firm reports Aug. 15. WorldHeart has requested that the agency grant it expedited review. A total of 270 patients have received the Novacor in North American clinical trials, in addition to 1,349 implants under the existing "bridge-to-transplant" indication (11"The Gray Sheet" June 17, 2002, p. 36)...

WorldHeart

PMA supplement covering Novacor left ventricular assist system as an alternative to transplant for end-stage heart failure patients is submitted to FDA, firm reports Aug. 15. WorldHeart has requested that the agency grant it expedited review. A total of 270 patients have received the Novacor in North American clinical trials, in addition to 1,349 implants under the existing "bridge-to-transplant" indication (11"The Gray Sheet" June 17, 2002, p. 36)...

MicroMed VAD Approval May Coincide With Inpatient Reimbursement Update

A new diagnosis related group, DRG 525 (heart assist system implants), could improve Medicare reimbursement for Thoratec's HeartMate-VE left-ventricular assist device as an alternative to transplant, pending FDA approval of the expanded indication

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