UPDATED Feb. 1, 2017, with comment from Biotronik.
The FDA this week released a warning letter it sent to Biotronik over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices.
In the letter, the federal watchdog referenced 6 specific violations and warned that “given the serious nature of the violations” that the agency was “taking steps to refuse entry of the devices into the United States.”
The 1st noted violation was a failure to ensure that processes which cannot be fully verified by subsequent inspections and tests are validated with a high degree of assurance and approved according to established procedures, and related to coatings used on its Selectra Catheter lead introducer system.
The FDA noted a failure to evaluate and select potential suppliers, contractors and consultants based on their ability to meet requirements, such as quality requirements. The agency also noted a failure to ensure environmental conditions would not have an adverse effect on product quality.
Failures to develop and maintain MDR procedures, to report information on malfunctions in a timely manner and to establish sampling methods were also noted in the FDA’s letter.
The firm was given 15 business days to respond to the letter and take steps to correct the violations.
A Biotronik spokeswoman told MassDevice.com via email today that the company responded to the FDA before the deadline and received an “all clear” letter Nov. 22, 2016.
“Biotronik expects a formal close-out by the FDA shortly,” she wrote.
Biotronik said it launched its Ilivia series of CRT-Ds, touting the devices as energy efficient units designed to address the 30% to 40% non-response rate in CRT patients without causing disproportionate battery drain.
“The launch of our latest generation of CRT-Ds and LV leads marks a significant expansion of our CRT portfolio. With a complete and innovative CRT solution, we want to empower physicians to offer a superior solution for heart patients that covers the entire duration of therapy and post-implantation care,” senior VP Manuel Ortega said in a press release.
The newly launched CRT-Ds include the company’s MultiPole Pacing technology, as well as ProMRI tech that allows the devices to be compatible with magnetic resonance imaging systems.
“Biotronik’s new CRT-Ds are equipped with numerous features that address physicians’ concerns about cardiac resynchronization therapy. The energy-efficient MultiPole Pacing has great potential to increase patients’ response to CRT and to sustain this in the long-term,” Dr. Christof Kolb of Munich, Germany’s German Heart Center said in prepared remarks.