St. Jude Medical, Inc. has gained U.S. FDA approval of the first-to-market MultiPoint™ Pacing technology.
Background
St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the U.S. in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure.
While quadripolar CRT technology has seen steady improvement, not all patients respond to the therapy. Also, non-responders to CRT are not able to be identified at the time of implant and individual patient response can be unpredictable. Studies have shown that activating more ventricular tissue faster may enhance heart muscle performance, which is where MultiPoint Pacing technology steps in, allowing as it does physicians the opportunity to capture more left ventricular tissue quickly by delivering pacing pulses to multiple left ventricle locations rather than the traditional single pulse for each heartbeat. Using the Quartet™ LV lead with its four uniquely spaced electrodes, physicians now have the capability to program two pulses from a single lead and tailor them to the specific needs of each patient.
St. Jude sees this approval as an important first step in the rollout of MultiPoint Pacing technology, and availability to U.S. physicians is expected in the first half of this year.
The company has also announced FDA approval of additional quadripolar pacing Quartet LV leads, which can be used with MultiPoint Pacing technology, as well as the programmer-based Auto VectSelect Quartet™ Test. The two new leads are designed based on Quadripolar LV lead technology and include additional electrode spacing options on two new S-curve shaped lead designs. The expanded family of Quartet LV leads offers more options to effectively meet the needs of patients with larger as well as smaller cardiac anatomies. Physicians can quickly customize therapy using the new automated Auto VectSelect Quartet Test, which is designed to offer comprehensive testing results so appropriate therapy options can be easily and efficiently programmed for each patient in a streamlined workflow.
Physician comments
“Having the ability to truly individualize cardiac resynchronization therapy is a significant step forward in the clinical approach to treating some of our most complex heart failure patients,” said Dr. Gery Tomassoni, director of electrophysiology at Baptist Health Lexington in Lexington, Kentucky. “MultiPoint Pacing technology provides a new set of tools that can be non-invasively programmed in an attempt to improve CRT response, thus opening up an important new treatment option for many patients who may need it.”
Company comments
“Continuing our quadripolar leadership, MultiPoint Pacing represents our commitment to invest and innovate in state of the art heart failure treatment options,” said Philip Ebeling, vice president and chief technology officer for St. Jude Medical. “These additions to our comprehensive CRT portfolio are examples of St. Jude Medical’s focus on providing physicians with technologies that result in effective patient outcomes and transform the treatment of some of the world’s most expensive epidemic diseases.”
Source: Business Wire
published: February 18, 2016 in: Approval/Clearance, Cardio, St Jude