Boston Scientific launches Resonate family of CRT-D devices in Europe
Feb 06, 2017
Introducing SmartCRT™ technology, providing MultiSite Pacing with up to 13.3 years battery lifei
Boston Scientific Europe today announced the launch of the RESONATE™ cardiac resynchronisation therapy defibrillator (CRT-D) systems in Europe, a new family of devices featuring SmartCRT technology, which recently received CE Mark and are now available for heart failure patients across Europe.
At present, 15 million people are living with heart failure in Europe and it is one of the few cardiovascular conditions whose prevalence continues to rise.ii The Resonate family of CRT-D systems offers SmartCRT technology, enabling physicians to offer a personalised care approach to all patients, including a wide range of options of where, when and how to pace. SmartCRT is also equipped with MultiSite Pacing, which offers two left ventricular pacing vectors. An observational study found this type of pacing achieved a 90 percent response rate from patients.iii
“We are very proud to launch the Resonate family of CRT-Ds in Europe and to be able to offer personalised therapy for the millions of people who live with heart failure,” said Professor John Morgan, Chief Medical Officer and Medical Director for Rhythm Management in Europe. “At Boston Scientific, we are committed to providing treatment options based on the most advanced technology for every patient and working to tackle the ongoing burden of heart failure.”
The Resonate family includes the RESONATE™ X4, CHARISMA™ X4, VIGILANT™ X4 and MOMENTUM™ X4 CRT-D devices. The adoption of newer CRT-D features can be limited due to device longevity, but the Resonate family is supported by the company’s EnduraLife™ battery technology, the only CRT-D battery that is clinically proven by nine independent studies to offer industry-leading longevity.iv-xii EnduraLife can offer up to 14.7 years battery life,i 13.3 years with MultiSite Pacing switched on,i meaning physicians and patients alike can have full confidence in the longevity of these devices.
“Despite decades of successful treatment with CRT–D therapy, 30 to 45 percent of patients still do not respond to treatment,” said Prof. Dr Ignacio Garcia Bolao, Director of the department of cardiology and Cardiac Surgery of the Clínica Universidad de Navarra in Pamplona, Spain. “Each patient with heart failure is different and the combination of MultiSite Pacing and battery longevity gives me the confidence and freedom to make treatment decisions based on what is needed for the individual patient.”
Heart failure is a serious chronic condition where the heart cannot pump enough blood to support the needs of other organs in the body leading to symptoms such as shortness of breath, extreme tiredness and swollen ankles and legs.xiii Heart failure is also the leading cause of hospitalisation in people over the age of 65 and carries a high cost to healthcare systems, as well as a significant cost on patients, their families and society.ii The 2016 European Society of Cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure recommend CRT device treatment for patients with heart failure, highlighting that the treatment can improve patients’ symptoms and general well-being, as well as reduce the risk of death.xiv
In Europe, the Resonate Family joins the growing line of ImageReady™ MR-conditional devices, all of which are labelled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the RESONATE CRT-D System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.
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i Assumes: 2.0V RA, LV-only, 2.0V LVa, 2.0V LVb, 700Ω, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure Sensor Suite
ii Cowie M, et al., Heart Failure Association of the ESC. Improving care for patients with acute heart failure. Before, during and after hospitalisation. 2014. https://www.oxfordhealthpolicyforum.org/reports/acute-heart-failure/improving-care-for-patients-with-acute-heart-failure
iii Zanon, et al. HeartRhythm 2016;13:1644–1651.
iv Haarbo J, Hjortshoj S, Johansen J, Jorgensen O, Nielsen J, Petersen H. Device Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators Differs Between Manufacturers: Data from the Danish ICD Registry. Presented at HRS 2014.
v J. Williams, R. Stevenson. Contemporary cardiac resynchronization implantable cardioverter defibrillator battery longevity in a community hospital heart failure cohort. Presented at HFSA 2014.
vi Ellis CR, Dickerman DI, Orton JM, Hassan S, Good EG, Okabe T, Andruilli JA, Quan KJ, Greenspon AJ. Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study. PACE 2016
vii Landolina M, Curnis A, Morani G, Vado A, Ammendola E, D’onofrio A, Stabile G, Crosato M, Petracci B, Ceriotti C, Bontempi L, Morosato M, Ballari GP, Gasparini M. Longevity of implant Cardioverter-defibrillators for cardiac resynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer. Europace2015;17:1251-58.
viii Zanon F, Martignani C, Ammendola E, Menardi E, Narducci ML, De Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, Iori M, La Rosa C, and Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement.
ix Provided by Dr. Ernest Lau on 04/29/15 in support of Lau E, Wilson C, Ashfield K, McNair W, McEneany D, Roberts M, Large Capacity LiMnO2 Batteries Extended CRTD Longevity in Clinical Use Compared to Smaller Capacity LiSVO Batteries Over 6 Years. Presented at HRS 2015.
x von Gunten S, Schaer BA, Yap SC, Szili-Torok T, Kühne M, Sticherling C, Osswald S, Theuns DA. Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time. Europace. 2015
xi Alam MB, Munir MB, Rattan R, Adelstein E, Jain S, Saba S. Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports.
xii Shabanna Din, Shabanna, Mcgee, Rao, Archana, Wright, Jay D. Longevity of implantable cardioverter defibrillators: The impact of device manufacturer and device type on device longevity were assessed
xiii NHS Choices. Heart Failure. https://www.nhs.uk/conditions/Heart-failure/Pages/Introduction.aspx# Last accessed January 2017
xiv European Heart Journal. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. 2016. https://eurheartj.oxfordjournals.org/content/ehj/37/27/2129.full.pdf. Last Accessed January 2017