St. Jude Medical (NYSE:STJ) enrolled the 1st patient in a clinical study evaluating pacing in multiple points on the heart, the company announced today.
The MultiPoint Pacing clinical trial will enroll more than 500 patients at 50 U.S. sites, implanting them with St. Jude’s next-generation Quadra Assura MP cardiac resynchronization therapy defibrillator matched with the company’s Quartet leads. The study is running under an Investigational Device Exemption with the U.S. FDA.
St. Jude’s line of quadripolar pacing systems, including the newly CE Marked Allure Quadra, can deliver multiple pacing pulses, either simultaneously or sequentially. Researchers are looking for indication that multi-point pacing may improve blood flow and cardiac function in heart failure patients.
"The Quadra Assura MP device builds upon the robust platform available with the current St. Jude Medical quadripolar technology and provides additional tools that may improve the CRT responder rate even further," St. Jude chief medical officer Dr. Mark Carlson said in prepared remarks. "This study represents our commitment to investing in product innovation and clinical evidence to ensure an increasing number of patients continue to respond to, and appropriately benefit from, CRT."
For the 1st 3 months patients enrolled in the trial will receive a standard single pacing pulse, at which point they will be categorized as either responders or non-responders to single-point CRT pacing. Patients will then be randomized to receive either continued single-point pacing or multi-point pacing, and will be observed for another 6 months.
"The MultiPoint Pacing trial is a study of patients who may not receive benefit or are unresponsive to standard CRT single-point pacing," Baptist Health Lexington electrophysiology director Dr. Gery Tomassoni said in prepared remarks. "We are evaluating whether MPP can increase the potential for a successful CRT outcome by pacing in multiple locations in the heart."
Last month St. Paul, Minn.-based St. Jude posted increased profits during the 1st quarter despite reporting lower sales. The medical device company said profits for the 3 months ended March 30 were $223 million, or 78¢ per share, on sales of $1.34 billion. That’s a 5.2% bottom-line gain compared with Q1 2012, but a 4.1% top-line reduction.
St. Jude’s cardiac rhythm management numbers were down, with pacemakers leading the decline at a 12% clip, to $251 million; implantable cardiac defibrillator revenues were down 5% to 427 million. That made for an overall CRM decline of 8%, to $678 million.
On Wall Street, STJ shares were down 0.3% to $40.58 as of about 12:55 p.m. today.
