BOSTON, MA — Boston Scientific has received approval from the US Food and Drug Administration (FDA) for MRI labeling of the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems, the company announced[1].
The FDA approved the devices for conditional use in an MRI environment.
“The MR-conditional labeling allows patients implanted with specific models of the company’s Resonate family of devices to receive full-body MR scans in 1.5-Tesla environments when conditions of use are met,” the company said in a statement. This capability also extends to patients implanted with Boston Scientific’s Autogen, Dynagen, and Inogen ICD and CRT-D devices.
MRI approval was based on clinical-trial results from the global ENABLE MRI study, which was completed earlier this year, the company said.
The Resonate ICD and CRT-D systems include the company’s HeartLogic heart-failure diagnostic, which alerts physicians to worsening heart failure in advance of an impending HF event by combining data from sensors evaluating heart sounds, respiration rate and volume, thoracic impedance, heart rate, and activity.
“The alert is the first and only heart-failure diagnostic in an implantable device that has been validated to have an observed sensitivity of 70% as well as the ability to provide weeks of advance notice—a median of 34 days ahead of an impending HF event—and low burden for detecting indications of worsening HF,” the company said.
“The HeartLogic Diagnostic provides physicians the ability to pivot from reactive heart-failure treatment to proactive care with a goal of improving patient outcomes and reducing heart failure–related hospitalizations,” Dr Kenneth Stein (Boston Scientific) said in the release.
In addition to the HeartLogic Diagnostic, all CRT-Ds in the Resonate family of devices contain the company’s SmartCRT technology to help physicians customize where, when, and how to pace the lower chambers of the heart using the Multisite Pacing capability for multielectrode pacing.
The company has started enrolling patients in the MANAGE-HF study to further evaluate the HeartLogic Diagnostic and has initiated a series of clinical trials to demonstrate improved response to CRT therapy with the SmartCRT technology.
“Through the MANAGE-HF study we will be able to realize fully the capabilities of the HeartLogic Diagnostic in clinical practice. We look forward to collecting additional data on how the alert can enable improved patient outcomes,” Dr Adrian Hernandez (Duke Clinical Research Institute, Durham, NC) and principal investigator of the MANAGE-HF study, said in the release.
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