Paris (June 26, 2013) – The first patient implant of the Boston Scientific Corporation (NYSE: BSX) VITALIOTM pacemaker was performed at ZGT Hengelo in Hengelo, the Netherlands. In addition to a comprehensive suite of features designed to optimize cardiac pacing, VITALIO features the Boston Scientific innovative AP ScanTM technology designed to help physicians identify patients with severe sleep apnea. Sleep apnea is a breathing disorder which, if left untreated, may lead to increased risk of high blood pressure, heart attack, stroke and heart failure.
“With the VITALIO device, we are able to gain insight into the patient’s sleep apnea status,” stated Salah Said, M.D., cardiologist, ZGT Hengelo, who performed the procedure. “It can help us potentially identify which patients may be suffering from sleep apnea and can also help us understand if prescribed sleep apnea treatments are having an impact.”
While sleep apnea is one of the most common comorbidities in patients with cardiovascular disease, and affects about 60 percent of those patients, as many as 80 percent of them remain undiagnosed. Sleep apnea is linked to a quadrupled risk of atrial fibrillation and a doubled risk of heart failure morbidity and mortality.
Dr. Said works together with neurologists, ENTs, and pulmonologists to treat sleep apnea patients with a collaborative approach. AP Scan is one tool that allows the team to understand if the treatment pathway is helping the patient’s overall sleep apnea status. Effective therapies are available to reduce sleep apnea and related effects, especially for obstructive sleep apnea, a type of sleep apnea in which the patient has pauses in breathing due to obstruction of the airways.
“Boston Scientific is focused on innovation and we are pleased to offer a broader portfolio for comorbidity management in the pacemaker population,” said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. “The VITALIO device is designed to provide a range of tools that can help physicians detect comorbidities earlier. This technology demonstrates our commitment to helping clinicians deliver the care and treatment their patients need.”
In addition to AP Scan, VITALIO follows the patient’s respiration with features such as RightRateTM and Respiratory Rate Trend for ensuring that patients receive pacing when they need it, at the rate they need it. VITALIO also offers radio-frequency (RF), which allows for efficiencies at implant and in follow-up, while allowing patients to automatically and wirelessly transmit important data about their health status to their physician. VITALIO is also MR-conditional, enabling patients to undergo full-body magnetic resonance imaging (MRI) scans for other health issues.
The device is also available in an Extended Longevity (EL) model with the biggest battery capacity and longest longevity on the market, built upon the same battery technology as the latest generation of the Boston Scientific implantable cardiac defibrillators (ICDs).
The VITALIO device has received the CE Mark and FDA approval.
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