On 14 February, Biotronik announced that the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronisation therapy defibrillator (ICD/CRT-D) series has received the CE mark approval.
The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRItechnology, which enables access to potentially life-saving MR scans. Furthermore, 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.
The first implantations of the Ilesto 7 second-generation ProMRIdevices are currently taking place across Europe. With its new Ilesto 7 series and existing Lumax 740 ICD/CRT-D series, launched in the European market in April 2012, Biotronik offers the world’s only two ICD/CRT-D series approved for MR scanning.
“The Ilesto 7 series, as well as many other Biotronik devices, boasts ProMRIcapability 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,” said Paul Erne, Lucerne Cantonal Hospital (LUKS), Lucerne, Switzerland, and one of the first physicians to implant the Ilesto device.
“As patients get older and have comorbidities,” Erne continued “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.”
Leonardo Calò from the Polyclinic Casilino, Rome, Italy, said: “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 ProMRI technology.”
“With all our innovations, patient safety comes first,” said Christoph Böhmer, president International, 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.”
The European market release of the Ilesto 7 series with ProMRI technology and the new DF4 connectors is expected in midyear 2013.
First implanters of the Ilesto 7 series are:
Leonardo Calò, Polyclinic Casilino, Rome, Italy;
Pascal Defaye, Grenoble University Hospital (CHU), Grenoble, France; Paul Erne, Lucerne Cantonal Hospital (LUKS), Lucerne, Switzerland;
Juan Gabriel Martínez, General de Alicante, Alicante, Spain;
Martin Jan Schalij and Lieselot van Erven, Leiden University Medical Center (LUMC), Leiden, Netherlands;
Tamas Szili-Torok, Erasmus Medical Center, Rotterdam (EMC), The Netherlands.