Boston Scientific has obtained CE Mark approval for its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4 quadripolar LV leads and the ACUITY PRO lead delivery system.
The company has also announced the first implants of the next-generation X4 quadripolar CRT-D systems. One of the first implants of the AUTOGEN X4 CRT-Ds was performed at Brescia University, Civili Hospital in Italy.
According to Boston Scientific, the X4 line of quadripolar CRT-Ds offers the largest number of pacing vector options in the industry and comes with a six-year warranty and industry-leading longevity.
The company also said the clinicians can effectively address high-pacing capture thresholds and phrenic nerve stimulation with the X4 CRT-Ds.
An independent, single-center, observational study of 646 CRT-D recipients implanted between 1 January 2008 and 31 December 2010 recently published in the US showed that during 2.7+/-1.5 years follow-up, only 4% of Boston Scientific device batteries had depleted, compared to 7% from St. Jude Medical and 25% from Medtronic.
Boston Scientific said that the X4 CRT-Ds use the same battery capacity and advanced battery chemistry as its devices used in this study.
The ACUITY X4 suite of quadripolar LV leads feature multiple electrode spacing configurations to accommodate individual patient anatomy, including 3D spiral designs to maximize electrode contact with the myocardium and minimize pacing capture thresholds in non-apical locations.
For optimizing stability, these quadripolar leads feature multiple fixation options. According to Boston Scientific, these leads have the industry’s smallest lead tip to enable physicians to access vessels unavailable to other quadripolar leads.
With the CE Mark approval for the X4 quadripolar CRT-D systems, the company plans to start a prospective, non-randomized observational study to collect additional data on ACUITY X4 leads in patients indicated for a CRT-D.
The Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY X4 (RALLY X4) study is anticipated to enroll approximately 1,000 patients who will receive the ACUITY X4 leads at approximately 100 centers across 18 countries.
Boston Scientific Europe senior vice president and president Michael Onuscheck noted heart failure is a major cardiovascular problem and CRT-Ds can save lives and improve quality of life.
"The CE Mark approval of our innovative quadripolar CRT-D systems is truly a milestone when it comes to treating patients with heart failure and at risk of sudden cardiac arrest. We are also excited to provide physicians with a CRT-D system that can significantly improve the implant experience," Onuscheck added.
Currently, the X4 quadripolar CRT-D system is approved for use in CE Mark countries only. The system is an investigational device in the US and is not available for sale in the country.