BIOTRONIK Announces FDA Approval Of MultiPole Pacing With ProMRI

BIOTRONIK has 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). 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. 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,” says 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,” says 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 360 degree CRT technologies are designed to better equip physicians to meet the therapy needs of heart failure patients. These technologies include:

• MultiPole Pacing — enables left ventricle to be paced sequentially or simultaneously
• MRI AutoDetect — shortens window of reduced therapy and eliminates the need for post-MRI reprogramming
• Closed Loop Stimulation — equips the device to respond appropriately to physiologic demands and acute mental stress
• Ultra-High Energy CRT defibrillator — provides up to 42J of energy to meet patient needs on first and every shock
• CRT-DX system — allows full CRT-D therapy with only two leads
• The thinnest leads approved for use in MR conditional CRT systems, including Sentus ProMRI QP, also launched today.
• BIOTRONIK Home Monitoring — automatically transmits device data daily; proven to reduce mortality in patients with heart failure by 50%3