EU Market Sees Launch Of World’s First MR Approved DF4 ICD/CRT-D System

Biotronik Ilesto 7

Pacing and remote monitoring technology company Biotronik has announced the European market launch of its Ilesto 7 Series. Ilesto 7 is the world’s first DF4 ICD/CRT series approved for MRI, one of the world’s smallest ICDs with up to 11.5 years longevity for the single chamber ICD.

Background

According to a Biotronik news release, the number of patients with ICDs continues to grow by 10 to 15 percent annually, with an estimated 50 to 75 percent of these patients likely to need an MR scan during the service lives of their devices. As patients live longer and frequently suffer comorbidities, a further increase is certain in the coming years.

Biotronik has been something of a pioneer in MR compatible CRT-D devices, its new Ilesto 7 Series and existing Lumax 740 ICD/CRT-D series, having been released in the European market in April 2012.

Being small, the Ilesto 7 Series and the new DF4 connector system claims to simplify and shorten the implantation procedure, while being comfortable for the patient with a satisfactory cosmetic result.

Biotronik’s remote monitoring systems have been well covered on our pages, the company’s Home Monitoring® offering both patient and physician what it calls the ultimate convenience of not requiring any patient interaction. Biotronik Home Monitoring® is the first and only wireless remote system with both FDA and CE approval for early detection of clinically relevant events and reduction of in-office follow-ups.

Physician comments

“We see a rising need for MR scans at our clinic and nationwide, and we acknowledge the steps BIOTRONIK has taken to develop its ProMRI® technology in order to help thousands of patients obtain the diagnostics they desperately need,” explains Dr. Juan Gabriel Martinez, Head of the Arrhythmia Unit of Hospital General Alicante, Spain.

Dr. Martinez implanted an Ilesto 7 HF-T in a 63-year-old patient suffering from cardiomyopathy. “Before BIOTRONIK launched its ProMRI® technology, patients with an ICD or CRT-D were prohibited from undergoing MR scans. Fortunately, with the new Ilesto system, I can offer my patients the option of an MR scan if they need one in the future. This is a very important aspect to my patients, as they have a high chance of needing an MR scan during the lifetime of their devices.”

Company comments

“With all our innovations, patient safety comes first,” notes Christoph Böhmer, President International of Biotronik. “Our patients have the peace of mind that their device and thus their cardiac health is constantly being monitored through Biotronik Home Monitoring®. In addition, Home Monitoring guided therapy has been shown to enable significant reduction of delivered shocks by 71%, as well as a reduction in hospitalization due to avoidance of inappropriate shocks by 73%.”

Source: Biotronik, SE & Co KG.