Medical devices manufacturer Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Acuity X4 quadripolar left ventricular (LV) leads for use with its cardiac resynchronization therapy (CRT) devices.
The company said quadripolar leads are the wires that link CRT devices to the heart.
With the approval, the company is now offering a full X4 CRT system, including the device and the leads, in the US market.
Featuring a 3D shape and four electrodes, Acuity leads can be easily placed in the vasculature, and will enable pacing at an optimal site to enhance the patient response to CRT therapy.
The approval was based on data from the Navigate X4 study, which is a non-randomized and multicenter clinical trial that enrolled 764 patients.
According to the company, the trial reached primary safety and efficacy endpoints through six months of follow up.
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."
The company also started the Enable MRI study at the beginning of this month, which is designed to support FDA approval for magnetic resonance imaging across its currently approved implanted cardiac defibrillation (ICD) and CRT systems.
Acuity X4 quadripolar LV leads will be used in the study, which will recruit about 500 patients at around 60 sites across the globe.
In the US, the MRI-conditional labeling will comprise existing and future families of extended longevity and Mini ICDs and the X4 cardiac resynchronization therapy defibrillator systems, including leads.
Image: Boston Scientific’s Acuity X4 quadripolar LV leads. Photo: courtesy of Boston Scientific Corporation.