The US Food and Drug Administration (FDA) has granted approval for Boston Scientific‘s Acuity X4 quadripolar left ventricular (LV) leads for use with its cardiac resynchronisation therapy (CRT) devices.
The company said that quadripolar leads are the wires that link CRT devices to the heart.
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With approval, the company is now offering a full X4 CRT system in the US market, including the device and the leads.
The Acuity leads feature a 3D shape and four electrodes, and can be easily placed in the vasculature, enabling pacing at an optimal site to improve the patient response to CRT therapy.
Approval was based on data from a non-randomised and multicentre Navigate X4 trial that enrolled 764 patients.
It is reported that the trial successfully met the primary safety and efficacy endpoints through six months of follow-up.
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By GlobalDataValley Hospital Health System Electrophysiology Laboratory director and principal investigator Suneet Mittal said: "Data collected in the Navigate X4 study demonstrate that these leads are safe and effective for use with CRT devices.
"The approval is a testament to the strength of the data in this trial, which also demonstrated fast lead implant times, stable lead placement, and improved pacing performance resulting from the unique design of the Acuity X4 leads."
Earlier this month, the company also started the Enable MRI study, which is designed to support FDA approval for magnetic resonance imaging across its currently approved implanted cardiac defibrillation (ICD) and CRT systems.
The Acuity X4 quadripolar LV leads will be used in the study, which will enroll approximately 500 patients at around 60 sites worldwide.
Boston Scientific cardiac rhythm management chief medical officer Kenneth Stein said: "We continue to enhance patient care with the launch of the uniquely designed Acuity X4 leads, which allow for optimal placement of pacing electrodes to improve the performance of CRT devices.
"Additionally, through our pursuit of MRI-conditional labelling, we maintain our commitment to bring new benefits to patients who currently have one of our devices or will receive one in the future."
In the US, the MRI-conditional labelling will include the existing and future families of extended longevity (EL) and Mini ICDs, as well as the X4 cardiac resynchronisation therapy defibrillator systems, including leads.
Last August, the company secured CE Mark on MRI conditional labelling on its EL and MINI ICDs and X4 CRT-D systems, as well as the Acuity X4 quadripolar LV leads, Ingevity and Fineline II pacing leads and Reliance 4-SITE and 4-Front defibrillator leads.
Image: Boston Scientific’s Acuity X4 quadripolar LV leads. Photo: courtesy of Boston Scientific Corporation.
