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XDx Hopes 510(k) For Heart Transplant Rejection Test Will Aid Reimbursement

This article was originally published in The Gray Sheet

Executive Summary

Molecular diagnostics firm XDx expects 510(k) clearance for its AlloMap HTx heart transplant rejection test, previously available as a laboratory home-brew, will lead to better reimbursement and market adoption

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Regulatory News In Brief

Power cord investigation: FDA is investigating power cords used in devices manufactured by Abbott, Hospira and other firms. Abbott and Hospira have collectively sent FDA 122 reports of sparking, charring and fires from defective device AC power cords manufactured by Westfield, Pa.-based Electri-cord Manufacturing Co. The power cord's prongs may crack and fail, potentially causing electrical shock, therapy delays or interruption, device failure or fires. FDA is determining which other device firms have been supplied with the cords and recommends that manufacturers that use the cords initiate voluntary recalls and report any adverse events to FDA. Hospira recalled more than 30 types of devices with the defective cords Aug. 14 (1"The Gray Sheet" Aug. 24, 2009). Electri-cord said Aug. 19 the problems must be related to "abusive use," such as yanking the cord out of the wall, rather than a manufacturing defect

Regulatory News In Brief

Power cord investigation: FDA is investigating power cords used in devices manufactured by Abbott, Hospira and other firms. Abbott and Hospira have collectively sent FDA 122 reports of sparking, charring and fires from defective device AC power cords manufactured by Westfield, Pa.-based Electri-cord Manufacturing Co. The power cord's prongs may crack and fail, potentially causing electrical shock, therapy delays or interruption, device failure or fires. FDA is determining which other device firms have been supplied with the cords and recommends that manufacturers that use the cords initiate voluntary recalls and report any adverse events to FDA. Hospira recalled more than 30 types of devices with the defective cords Aug. 14 (1"The Gray Sheet" Aug. 24, 2009). Electri-cord said Aug. 19 the problems must be related to "abusive use," such as yanking the cord out of the wall, rather than a manufacturing defect

Financings In Brief

HeartWare raises $55 million in wake of failed Thoratec merger: Ventricular-assist device maker HeartWare raises $55 million in a private placement of 2.5 million common stock shares at $22 each, announced Aug. 10. The funds will help sustain development efforts for the firm's HeartWare Ventricular Assist System with HVAD pump in the wake of Thoratec's failed bid to acquire the company for $282 million. Thoratec pulled out of the deal July 31 after the Federal Trade Commission raised antitrust concerns (1"The Gray Sheet" Aug. 3, 2009). Headquartered in Sydney, Australia, and Framingham, Mass., HeartWare will use the proceeds from the private placement "for the furtherance of its clinical and commercial roll-out of the HeartWare HVAD and its pipeline of future pumps," the company says in a filing with the Securities and Exchange Commission. The system received CE mark approval in Europe for bridge-to-transplant therapy in January; a 150-patient U.S. trial is ongoing for the same indication (2"The Gray Sheet" Feb. 16, 2009)

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