Natick, MA-based Boston Scientific (NYSE: BSX) has enrolled its first patient in its MultiSENSE clinical trial, which will study the early alerts of heart failure. The trial combines the company's patient management system, LATITUDE, with its COGNIST cardiac resynchronization therapy defibrillators (CRT-Ds) to promote clinical action and prevent hospitalization in heart failure patients.
"Boston Scientific's unique multi-sensor approach is designed to allow our CRT-Ds to assess the same symptoms and data a doctor evaluates when seeing a heart failure patient in the office," says Kenneth Stein, chief medical officer for Boston Scientific's cardiology, rhythm and vascular group. More than 22 million people suffer from heart failure, with one million new diagnoses every year.
In March, the company voluntarily recalled ICDs and CRT-Ds after finding out manufacturing changes hadn't received FDA approval. The company was allowed to sell its remaining offending difibrillators, as they posed no risk to patients.
The company's shares were down 1.2 percent to $6.21 in mid-morning trading Thursday, according to MassDevice.