In short
Cardiac pacing and remote monitoring company Biotronik has announced that its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE approval.
Background
The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI® technology, which enables access to potentially life-saving MR scans. Furthermore, Biotronik says Ilesto offers patients and physicians the greatest longevity available — up to 11.5 years for the single chamber ICD and 7.5 years for the CRT-D device.
In addition Biotronik says the devices’ optimised shape and the new DF4 connector provide a number of important benefits for both physicians and patients. Patients also benefit from secure remote monitoring via Biotronik Home Monitoring®.
Physician comments
Prof. Dr. Paul Erne from Lucerne Cantonal Hospital (LUKS), Lucerne, Switzerland, one of the first physicians to implant the Ilesto device, explains, “The Ilesto 7 series, as well as many other Biotronik devices, boasts ProMRI® capability and Biotronik’s Home Monitoring® technology. With this, we have the opportunity to offer our patients the most advanced and reliable ICD and CRT-D therapy, an enhanced quality of life, and an opportunity to live as normal a life as possible.”
“As patients get older and have comorbidities,” Prof. Erne continues, “they often require MR scanning at some point in the future. With Ilesto 7 I can ensure that my patients will have access to the gold standard of soft tissue imaging when needed — even with an ICD or a CRT-D.”
About the remote monitoring function, Dr. Leonardo Calò from the Polyclinic Casilino, Rome, Italy, reports; “Patients feel more comfortable post implant. They leave with peace of mind knowing that they will be constantly monitored via Biotronik Home Monitoring®, that they will receive an in-office follow-up when needed, that their physicians can initiate their therapy at a very early stage, and that they will receive the right treatment. They also know that they can undergo the most advanced diagnostic procedure available today as a result of having an ICD or CRT-D with Biotronik´s ProMRI® technology.”
Company comments
“With all our innovations, patient safety comes first,” says Christoph Böhmer, President International at BIOTRONIK. “Our Ilesto implants and Linox Smart leads are designed to continue our tradition of providing products with the highest reliability. Furthermore these devices bring patients a number of important safety benefits, including a reduced risk of inappropriate shocks, stroke, and other comorbidities.”
Source: Biotronik SE & Co. KG, Marketwire
published: February 19, 2013 in: Approval/Clearance, Biotronik, Cardio