BIOTRONIK Announces FDA Approval of MultiPole Pacing with ProMRI: 360
Comprehensive Solution Exemplifies BIOTRONIK’s Commitment to Patient Care
BIOTRONIK today announced FDA approval of the company’s MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT).1 MPP will be available on new BIOTRONIK CRT defibrillator (CRT-D) systems for patients with heart failure.
Nearly 40 percent of heart failure patients are initially non-responsive to CRT.2 BIOTRONIK’s innovative MPP technology addresses this challenge by enabling the left ventricle to be paced twice per cardiac cycle. Uniquely, these paces can be either sequential or simultaneous, allowing for greater customization of therapy to meet specific patient needs. BIOTRONIK CRT-D systems include MPP and feature ProMRI® technology, providing patients with access to critical diagnostic imaging scans as needed. These devices are also equipped with MRI AutoDetect, a dedicated sensor that detects the MRI environment, converts the patient’s device to MRI mode, and then automatically returns to its permanent program when the scan is complete.
With the availability of MPP, BIOTRONIK now offers the most comprehensive MR conditional CRT portfolio available today to ensure physicians have access to the best possible cardiac rhythm management solution.
“MultiPole Pacing is an important technology that allows physicians to tailor cardiac resynchronization therapy to each patient,” said Dr. Gery Tomassoni, Baptist Health, Lexington, Kentucky. “Heart failure is a complex condition and physicians are routinely challenged to find the ideal treatment for unique disease presentations. Adding MPP technology to other key BIOTRONIK features creates more options for physicians to meet evolving patient needs.”
“When we develop technologies and evolve our devices, we think first and foremost about patients. Patients deserve the best care possible and innovation that truly enhances everyday life,” said Marlou Janssen, President of BIOTRONIK, Inc. “Patients with heart failure are the most complex to treat, and they often have additional comorbidities that are likely to change and worsen over time. BIOTRONIK rises to this challenge by continuing to innovate, and offering impactful, customizable solutions to physicians that meet the ever-changing landscape of patients’ needs.”
BIOTRONIK’s 360o CRT technologies are designed to better equip physicians to meet the therapy needs of heart failure patients. These technologies include:
1 Outcomes from use of BIOTRONIK MultiPole Pacing feature may be different than results obtained during St. Jude Medical MultiPoint Pacing (MPP) IDE study of their similar feature. The clinical effectiveness of this feature has not been established. BIOTRONIK is conducting an FDA-required post approval study to demonstrate that the MultiPole Pacing feature is effective by converting a percentage of CRT non-responders to responders.
2 Mullens W et al. JACC. 2009, 53 (9).
3 Hindricks G, et al. The Lancet. 2014, 384 (9943).
4 Not currently available in the United States.
5 CAUTION – Investigational device. Limited by United States law to investigational use.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.