
Another deal went south for Thoratec Corp. (NSDQ:THOR), this time over concerns with its International Technidyne Corp. division’s regulatory and quality systems and the failure of a key product to win a green light from the Food & Drug Administration.
The Pleasanton, Calif.-based cardiac assist device maker scuttled its deal with Danaher Corp. (NYSE:DHR) for a $110 million buyout of ITC, saying the parties couldn’t agree on "the status of certain aspects of ITC’s quality system and regulatory filings," according to a press release.
ITC, which makes diagnostics and blood monitoring systems, also failed to win 510(k) clearance from the Food & Drug Administration for its ProTime InRhythm device, an in vitro diagnostic device designed to measure prothrombin time in blood samples.
Thoratec said it will now focus on winning clearance for the device, with a new 510(k) submission to come by the end of the year, while pursuing other suitors for ITC. Its board of directors expects a sale to occur in the next 12 months, according to the release.
It’s not the first time the company has seen a deal founder. Last year, Thoratec‘s $282 million deal to buy rival HeartWare International Inc. (NSDQ:HTWR) collapsed after the Federal Trade Commission said it would move to block the deal on anti-trust grounds.
When it announced the ITC/Danaher deal in April, Thoratec said the sale would allow it to focus on its core vascular assist device business. The deal called for Danaher to pay $100 million up front, with potential earn-outs pegged to gross profit benchmarks of another $26 million payable over three years.