Thoratec Corporation, a maker of device-based mechanical circulatory support therapies, announced that it has canceled the previously-announced $110 million deal to sell its International Technidyne Corporation (ITC) division to Danaher Corporation. The two sides couldn't agree on the status of ITC's quality system and regulatory filings. Additionally, the FDA denied approval of ITC's ProTime InRhythm, causing Thoratec and Danaher to disagree on whether closing conditions of the deal were met.
Thoratec says ITC will focus on gaining 510(k) clearance for InRhythm. The company plans to file a new submission for the device by the end of 2010. Thoratec's board of directors still expects it will be able to sell ITC off in the next twelve months.
- read the Thoratec release