Boston Scientific Corp. (NYSE:BSX) is looking to get back on its feet after a series of mis-steps for its cardiac defibrillator operations.
The Natick, Mass.-based medical device maker enrolled the first patient in its MultiSense clinical trial, aimed at evaluating the use of multiple sensors with its Cognis cardiac resynchronization therapy defibrillators.
Boston Scientific said it plans to use the trial data to develop a system for eaerly warning of worsening heart failure in patients implanted with the device.
The idea is to combine the multi-sensor Cognis model with Boston Scientific‘s Latitude patient management system, which wirelessly transmits data from the CRT-D to the patient’s physician.
It’s a bit of good news for the company’s troubled defibrillator operation, which voluntarily shut down manufacturing and pulled all field inventory of its implantable cardiac defibs and CRT-D devices March 15 after discovering it had failed to register manufacturing changes with the Food & Drug Administration. The FDA cleared the company to resume sales of its Cognis and Teligen devices a month later and cleared all defibrillator sales May 21.
But the hold — estimated to have cost the company about $5 million a day — helped tear a $1.8 billion hole in Boston Scientific’s bottom line during the first three months of 2010. First-quarter losses reached $1.6 billion and the company said the hold could wind up delivering a $500 million hit in lose sales this year.
BSX shares were down 1.2 percent, to $6.21 from a $6.33 open, in mid-morning trading.