BIOTRONIK has announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronisation therapy pacemaker (CRT-P) with MRI AutoDetect technology. With a volume of 15 cc, Edora HF-T QP is the smallest MR conditional CRT-P available in the US with longevity of nearly 10 years, reducing the frequency of device replacements for heart failure patients.

BIOTRONIK won FDA approval and is releasing in the U.S. its Intica DX and Intica cardiac resynchronisation therapy (CRT)-DX implantable cardioverter defibrillators (ICD). The DX indicator refers to BIOTRONIK’s technology that obviates the necessity of having an atrial lead to monitor the electrical activity in the atrium, a way that cardiologists use to spot atrial fibrillation and other more serious arrhythmic events.

BIOTRONIK has announced the results of the BIOFLEX-I clinical study and availability of Pulsar-18 for the treatment of patients with peripheral artery disease (PAD). Pulsar-18 is the only superficial femoral artery (SFA) self-expanding stent approved by the FDA with a 4-French (4F) delivery system, enabling simpler, safer and more efficient procedures than larger diameter delivery systems.

BIOTRONIK has received CE approval for 3T full-body scans (FBS) with its latest range of MR conditional pacemaker systems. Patients implanted with single- and dual-chamber pacemakers from the Edora/Evity/Enitra series can now benefit from ultra-high field MRI scans without any restrictions on the scanned body area. BIOTRONIK’s ProMRI pacemaker portfolio was previously approved for 1.5T FBS. With 3T FBS compatibility, radiologists can o...

  BIOTRONIK has announced the availability of the Edora line of devices, the company's first available pacemaker series featuring BIOTRONIK's MRI AutoDetect technology. Edora SR-T is the smallest MR conditional pacemaker with automated MRI detection capability available in the US with a volume of 10 cc and weight of 20.8 g.

BIOTRONIK has announced the commercial launch of Solia S ProMRI, with a 5.6 French lead body, the smallest MR conditional pacing lead available in the United States. Solia S ProMRI is available in 45, 53 and 60 centimeter lengths. Solia received FDA approval on June 9, 2016 based on data collected during the Pre-Market Study (IDE) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with sta...

With the launch of the Edora series, BIOTRONIK has brought the highest functionality to its smallest pacemakers as well as cardiac resynchronisation therapy pacemakers (CRT-Ps). The new devices are equipped with features geared towards improving patient safety, therapy and comfort. Moreover, Edora pacemakers are significantly smaller and lighter than preceding models, achieving compactness and full functionality without compromising battery life.

BIOTRONIK has just landed its first FDA approval for a coronary stent. The PRO-Kinetic Energy CoCr metal stent is intended for placement within narrow arteries, only between 2.25 and 4 mm in diameter, and features struts that are nearly microscopic at 60 µm in width. The narrow struts and the helical design make the stent very flexible for easier delivery through tortuous vasculature.

BIOTRONIK is releasing a new line of cardiac resynchronisation therapy (CRT) implants, the Ilivia series, that are designed to improve patient response to the therapy and make it customisable for individual needs. The devices are compatible under MRI and feature the company’s MRI AutoDetect capability that automatically switches the devices to a special safe mode during an MRI scan.