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BEFLEX MRI Pacing Lead

Catalogue: Outside USA

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EASY1, FAST2,SAFE3  Active Bradycardia MRI leads

  • Reliable “Pin Driven” mechanism for easy extension/retraction of the helix
  • Proven technology4
    • Over 20,000 leads implanted worldwide
    • 99.95%  reliability after 3 years
  • Very good X-Ray visibility
  • Good electrical performances5

  BEFLEX RF 45D BEFLEX RF 46D
  Implant

Follow up

(1 month)

Implant

Follow up

(1 month)

Threshold at 0.5ms 0.61V±0.5V 0.65V±0.2V 0.49V±0.1V 0.78V±0.4V
Sensing 3.61mV±1.7mV 3.74mV±1.8mV 11.63mV±3.7mV 12.03mV±3.9mV
Impedance 588±148 532±95 721±184 651±158

During the follow up period of Pleasure-S Sorin Clinical Study, electrical performances were stable and clinically acceptable in all patients as expected. The sponsor observed that 90% of pacing threshold values were less than 1,25V in each chamber. Sorin data on file.

 

REFERENCES

  1. During Pleasure-S Clinical Study, 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. Sorin data on file.
  2. During Pleasure-S Clinical Study, 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. Sorin data on file. Sorin data on file.
  3. During Pleasure-S Clinical Study, it has been demonstrated that the BEFLEX leads provided low acute pacing thresholds and satisfying impedance values in both chambers. 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. Sorin data on file.
  4. Sorin Group Product Performance Report,p43, May 2014.
  5. During Pleasure-S Clinical Study, electrical performances were stable and clinically acceptable in all patients as expected. Sorin data on file. 

This product is not available for sale or distribution in the USA. For further information on product availability, please contact your local representative

Features

EASY1

  • 6 F lead body, 7 F introducer: easy access to smaller veins and easy insertion of two BEFLEX leads at the same location2
  • Coaxial structure gives very good x-ray visibility of the lead body
  • X-ray marker for clear checking of the helix extension
  • A reliable pin driven mechanism for easy extension/retraction of the helix
  • Large choice of stylets and butterfly tool design that helps to make the implant easier

 


FAST3

Result of a handling survey performed during clinical evaluation on more than 200 leads implanted; the investigators evaluated and compared BEFLEX handling to other similar models that are typically used.

  • Fast lead advancement through the vein thanks to the lubricious silicone insulation
  • Very fast lead tip positioning confirmed by the evaluation of more than 200 implants
  • Very good maneuverability in the chamber


SAFE4

Remarkable electrical performances confirmed by more than 200 leads6

  • Very low pacing thresholds
  • Improved sensing specificity
  • High impedances for increasing pacemaker longevity

 

REFERENCES

  1. During Pleasure-S Clinical Study, 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. Sorin data on file.

  2. During Pleasure-S Clinical Study, 99% of clinical evaluation investigators concluded that BEFLEX leads had either “equal”, “better” or “the best” ease of use with recommended introducer without guidewire when implanted in the atrium when compared to other similar models typically used by investigators; 91% of investigators concluded that BEFLEX leads had either “equal”, “better” or “the best” ease of use with recommended introducer with guidewire. Sorin data on file.

  3. During Pleasure-S Clinical Study, 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. Sorin data on file. Sorin data on file.

  4. During Pleasure-S Clinical Study, it has been demonstrated that the BEFLEX leads provided low acute pacing thresholds and satisfying impedance values in both chambers. 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. Sorin data on file.

  5. Sorin Group Product Performance Report,p33, May 2014.

  6. During Pleasure-S Clinical Study, electrical performances were stable and clinically acceptable in all patients as expected. Sorin data on file.

 

This product may not be for sale in your country or your area. For further information on product availability, please contact your local representative

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