US-based Boston Scientific has initiated the patient enrolment in a clinical trial of its Acuity X4 quadripolar left-ventricular (LV) pacing leads and Reliance 4-Front defibrillation (ICD) leads in the US.
The objective of the Navigate X4, a prospective, non-randomised, multi-centre, global clinical study is to establish the safety and effectiveness of both lead families to satisfy US Food and Drug Administration (FDA) requirements for the PMA submission.
In addition, data from this study will be used to support the FDA approval of these devices.
The trial is slated to enroll between 1,542 and 2,290 patients at up to 125 centres in the US, Canada and Israel.
The Acuity X4 and Reliance 4-Front leads will be connected to commercially available Boston Scientific X4 CRT-D devices.
According to the company, Acuity X4 LV leads are designed to maximise effectiveness and minimise unnecessary patient interventions after implants.
The Acuity X4 incorporates a unique 3D spiral design intended to minimise floating electrodes for better electrical performance.
In addition, dual-fixation zones and the 2.6 French crossing profile are designed to optimise lead stability and reduce the risk of dislodgement.
When an Acuity X4 lead is connected to a Boston Scientific X4 CRT-D, the 17 pacing vector options will enhance physicians' ability to manage unexpected complications electronically through programming rather than an invasive lead revision.
The Reliance 4-Front ICD lead is built upon the demonstrated performance and reliability of the Reliance lead platform over the long term. It incorporates the same design principles as Endotak Reliance lead, yet offers improved handling and manoeuvrability.
The Reliance 4-Front ICD lead also features a secured Gore coating, designed to prevent tissue in-growth and enable both a streamlined implant experience and easier extraction in case of infection.
While the Acuity X4 lead and Reliance 4-Front ICD leads are already CE Marked, they are investigational devices and are not yet available for sale in the US.
Boston Scientific Rhythm Management senior vice-president and chief medical officer Dr Kenneth Stein said the Acuity X4 and Reliance 4-Front leads will provide physicians with better options to improve patient care.
Image: Boston Scientific's corporate headquarters in Natick, Massachusetts. Photo: courtesy of Boston Scientific Corporation.