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HCFA Conditional Coverage For Clinical Trials Unlikely In Near-Term

This article was originally published in The Gray Sheet

Executive Summary

The Health Care Financing Administration will not provide "conditional coverage" under Medicare for the ongoing REMATCH trial evaluating congestive heart failure treatment using Thermo Cardiosystems, Inc.'s HeartMate left ventricular assist device.

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First human implant of the coronary stent system for small vessels is performed July 11 at Sacred Heart Medical Center in Eugene, Oregon. The stent is intended to treat threatened abrupt closures of first-time or recurring blockages in small vessels with diameters of less than 3.0 mm. Separately, the firm has launched a multi-center safety and feasibility study to evaluate the AccuNet embolic protection system to reduce stroke during minimally invasive carotid artery stenting procedures. Guidant had submitted an IDE for the 50-patient study in May (1"The Gray Sheet" May 29, p. 3)

Guidant Multi-Link Pixel

First human implant of the coronary stent system for small vessels is performed July 11 at Sacred Heart Medical Center in Eugene, Oregon. The stent is intended to treat threatened abrupt closures of first-time or recurring blockages in small vessels with diameters of less than 3.0 mm. Separately, the firm has launched a multi-center safety and feasibility study to evaluate the AccuNet embolic protection system to reduce stroke during minimally invasive carotid artery stenting procedures. Guidant had submitted an IDE for the 50-patient study in May (1"The Gray Sheet" May 29, p. 3)

HCFA Support Of CREST Study Could By Aided By White House Directive

President Clinton's June 7 executive memorandum aimed at increasing the participation of Medicare beneficiaries in clinical trials could facilitate federal reimbursement for studies of currently non-covered procedures, such as the CREST carotid stent trial.

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