Sunshine Heart, Inc. (SSH, SHC.AX) said it has received conditional approval from the FDA for its next generation C-Pulse System driver. This new iteration is designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance.
The new driver features a single unit which is lighter, quieter and approximately half the size of its predecessor and also features a number of software enhancements.
Conditional approval from the FDA allows the company to use this next generation driver for investigational purposes in the U.S. at all sites that are currently enrolled in Sunshine Heart's North American feasibility trial. Sunshine Heart plans to provide the C-Pulse driver to all patients currently on its C-Pulse device at all U.S. sites upon Institutional Review Board approval. This second generation driver is also expected to be used in the Company's future U.S. pivotal trial once the FDA has approved the company's investigational device exemption, or IDE, as well as in Europe.
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