BIOTRONIK Announces the Global Launch of its New ICD and CRT-D DF4-based DX Lead

Published
Monday, April 29, 2019

The Innovative DF4 Lead Design of Plexa ProMRI S DX Helps Ease Implant Procedures and Improve Aesthetic Outcomes

BERLIN, Germany, April 29, 2019 – BIOTRONIK announced today the availability of its Plexa ProMRI S DX lead, with DF4/IS-1 connector in Europe and the US. The lead is an extension of BIOTRONIK’s Plexa family. Together with the new lead and recently launched Acticor/Rivacor ICD and CRT-D devices, BIOTRONIK offers DF4-based DX systems for tachycardia therapy, designed to meet the needs of both physician and patient. The innovative DX Technology allows complete atrial diagnostics in a single-lead ICD, enabling the timely detection of asymptomatic atrial fibrillation (AF).

Multiple benefits for both patients and physicians convinced first implanters in a post-market observation (PMO). “My first experience with the new ICD and CRT-D lead is very positive”, commented Dr. Peter Nordbeck, Head of Cardiology at the University Hospital Würzburg, Germany. “Compared to traditional ICD systems, the DX concept combines the main strengths of dual-chamber ICD functionality without the downsides of an additional atrial lead. The reduced number of connector-pins in the lead now results in a better workflow and even less susceptibility to lead problems. Due to the reduced size of the lead yoke and of the device header in comparison with the former DF-1 DX lead and device, my patients additionally benefit from smaller pockets, and thus a much better cosmetic outcome.” More than 80 percent of implanters in the PMO agreed with this statement.1 Acticor/Rivacor devices from BIOTRONIK’s latest ICD and CRT-D family further support this aesthetic result. The device family’s 10 mm slim size and smooth shape result in less skin pressure2 and a simpler implant procedure3.

In addition, 97 percent of implanters evaluated implantation workflow and device connection using the improved lead “much better or better” in comparison to previous models.4 Plexa ProMRI S DX also features BIOTRONIK’s Helix Design for stress reduction on the lead body in the intracardiac region, and is approved for 3T full-body MRI scans. The new lead with DF4 connector has received both FDA approval and CE mark.

“Plexa ProMRI S DX is built on proven BIOTRONIK lead elements that are designed to withstand long-term stress,” said Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. ”Our development team in Berlin worked very successfully to advance our lead portfolio ─ making BIOTRONIK’s unique DX Technology and stress-resistant Helix design now available with DF4 standard.”

When the DX Technology is used together with BIOTRONIK Home Monitoring®, prompt intervention for AF management is possible, reducing patients’ risks of further complications and related hospitalization.5,6

About BIOTRONIK

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.

References

  1. Post-Market observation Plexa ProMRI S DX; final-report, April 11, 2019. Data on file.
  2. Device shape analysis Acticor/Rivacor, February 2019. Data on file.
  3. Post-Market observation Acticor/Rivacor; final-report, March 1, 2019. Data on file.
  4. Post-Market observation Plexa ProMRI S DX; final-report, April 11, 2019. Data on file.
  5. Mabo P et al. A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (The COMPAS Trial). European Heart Journal. 2012; 33: 1105 –11.
  6. Guédon-Moreau L et al., Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: A sub-study of the ECOST trial. J Cardiovasc Electrophysiol. 2014; 25(7): 763 – 70.