1. 99% of clinical evaluation investigators concluded that BeFlex leads had either "equal", "better" or "the best" X-ray visibility of the lead body in the atrium when compared to other similar models typically used by investigators; 97% of investigators concluded that BeFlex leads had either "equal", "better" or "the best" maneuverability in the ventricle; 95% of investigators concluded that BeFlex leads had either "equal", "better" or "the best" overall ease of lead placement in the ventricle; 94% of investigators concluded that BeFlex leads had either "equal", "better" or "the best" Ease of extension/retraction of helix in the ventricle.

 

2. 97% of clinical evaluation investigators concluded that BeFlex leads had either "equal", "better" or "the best" Lead advancement through the vein in the atrium when compared to other similar models typically used by investigators; 96% of investigators concluded that BeFlex leads had either "equal", "better" or "the best" Lead tip positioning in the ventricle; 94% of investigators concluded that BeFlex leads had either "equal", "better" or "the best" Lead placement time in both the atrium and the ventricle.

 

3. During clinical evaluation, it has been demonstrated that the BeFlex leads provided low acute pacing thresholds and satisfying impedance values in both cavities. The amplitudes, impedance values and thresholds were stable during the one month follow up; In the clinical evaluation, the sponsor noted that the preliminary clinical data has provided sufficient proof that the Beflex lead is safe and effective for its intended use.

 

BEFLEX leads are not available in the USA.