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New Products In Brief

This article was originally published in The Gray Sheet

Executive Summary

Right side of heart pump: FDA grants Humanitarian Device Exemption on Oct. 7 to Levitronix' CentriMag right ventricular assist system for temporary support of critically ill patients with a failing right ventricle. Safety data from two multi-center clinical trials showed that the benefits of CentriMag outweigh its risks, FDA says. The device is designed to support patients up to 14 days or until a heart transplant or long-term heart assist device can be implanted. "While severe right-side heart failure is uncommon, it can lead to death," states FDA. "It is often caused by left-side heart failure or, in unusual cases, by heart surgery.

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Regulatory News In Brief

Integra Class I recall: Firm's NeuroSciences unit initiated a recall Oct. 3 of its Gravity Compensating Accessory (GCA) used in implanted shunt systems because the device may leak cerebrospinal fluid, potentially causing inflammation of brain, spinal cord or abdominal membranes, or failure of the shunt system, FDA says in a Dec. 11 Class I recall notice. The GCA is part of a system that redirects excess fluid from the brain to the abdomen so that too much fluid does not build up while sitting or standing. Integra sent letters to customers on Oct. 9, as well as to physicians. The devices were manufactured between January and May, and were distributed from Feb. 22 to June 1

Venture Funding Deals: Sumitomo Alliance With Roivant Takes Shape

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Venture Funding Deals column provides a comprehensive monthly review of emerging biopharmaceutical companies that have received venture funding. This month’s column covers deals announced October to November.




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