Healthcare Equipment and Supplies
Company Overview of BIOTRONIK SE & Co. KG
BIOTRONIK SE & Co. KG designs, develops, manufactures, and markets cardio and endovascular medical devices in Germany and internationally. It offers products for bradycardia therapy, including pacemakers, leads, and external devices; tachyarrhythmia therapy, such as ICDs, leads, and external devices; ablation and diagnostic catheters, and temporary pacing for electrophysiology; and CRT devices and accessories for cardiac resynchronization. The company also provides coronary drug eluting and self-expanding stent systems, coronary balloon-expandable stent systems, drug releasing balloon catheters, balloon catheters, guide wires, and accessories for coronary and peripheral vascular intervention...
Founded in 1963
Key Executives for BIOTRONIK SE & Co. KG
Managing Director and Member of Executive Board
Senior Director of Corporate Communications
Director of Marketing for Vascular Intervention
Compensation as of Fiscal Year 2015.
BIOTRONIK SE & Co. KG Key Developments
FDA Approves Expansion of BIOTRONIK ProMRI(R) ICD Trial to Include Full-Body Scans and DX Technology
May 22 14
BIOTRONIK announced that the Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI(R) trial. The approval will allow patients enrolled in Phase C of the trial to receive full-body scans, and for the first time include patients with DX implantable cardioverter defibrillators (ICDs) in the study. The unique BIOTRONIK DX ICD system provides physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms with only a single lead. BIOTRONIK introduced DX technology in 2013 in the U.S., and it has been quickly adopted by electrophysiologists nationwide. Patients prefer implants with less hardware while physicians benefit from dual-chamber diagnostic data. Phase C of the ProMRI(R) trial is the final phase in a series of ground-breaking MRI compatibility trials conducted by BIOTRONIK in rapid succession. Phase A and Phase B of the trial evaluated the safety of BIOTRONIK Entovis pacemaker systems during MRI scans. Phase A resulted in FDA approval on May 6, 2014 of Entovis systems for MRI scans with an exclusion zone. Phase B expanded the trial to evaluate the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans. Phase B is nearing completion and data will soon be submitted to the FDA.
Food and Drug Administration Approves Expansion of BIOTRONIK's Ongoing ProMRI Trial
Mar 13 14
BIOTRONIK announced that the Food and Drug Administration (FDA) has approved the expansion of BIOTRONIK's ongoing ProMRI trial. The new phase of the trial (Phase C) will study the company's ProMRI technology in implantable cardioverter-defibrillator (ICD) devices. The first phase of the ProMRI trial (Phase A) evaluated the safety of the BIOTRONIK Entovis pacemaker systems during MRI scans, excluding scans in the chest area. This phase was completed on November 18, 2013, and the FDA is now conducting its review of the Pre-Market application. Earlier that same month, the FDA had approved Phase B of the study, which expanded the trial to evaluate the safety of these pacemaker systems during MRI scans including cardiac and thoracic spine scans. Phase B has already enrolled more than 100 of the planned 245 patients, and will continue concurrently with the newly approved ICD phase of the study. The latest phase of the ProMRI clinical study aims to determine whether ICD patients can safely undergo MRI scans with an exclusion zone. The study will recruit and evaluate 172 patients at 35 U.S. investigational centers. The ICD ProMRI with exclusion zone study is designed to confirm the safety and efficacy of BIOTRONIK's Iforia devices, with Setrox and Linox(smart) leads during an MRI scan. All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.
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