Kora 250

Catalogue: Outside USA
cover-photo.png

The World's Smallest Full-Body MRI Conditional Pacemaker*

Kora 250

A physiologic pacemaker family designed to improve patient outcome while driving efficiency in practice1,2,3. Powered by intelligent algorithms including:

  • AutoMRI Mode
  • Sleep Apnea Monitoring (SAM)
  • SafeR

 

*Dual-chamber, Implanted with Beflex lead(s)

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

Features

Auto MRI Mode

Making MRI scans easy and safe for pacemaker patients.4

Detects the magnetic field of the MRI machine and automatically switches to asynchronous pacing. Returns to physiologic pacing five minutes after the patient leaves the MRI machine, thus avoiding the need for a second visit to the cardiologist.

Take the work out of workflow >

One flexible visit | Cardiologist sets MRI mode to "Auto" and selects time window for strong magnetic field detection (up to 48h)

Automatic switch to normal configuration | Switches back 5 minutes after the patient is removed from the strong magnetic field

Limited time spent in asynchronous mode

 

SLEEP APNEA MONITORING - SAM

Early detection, long term risk reduction.5,6,7,8,9

SAM is a unique sleep apnea monitoring tool providing reliable, automatic screening to detect severe sleep apnea.

SAM & PSG GOLD STANDARD >

SAM has been validated against the gold standard apnea-hypopnea index determined by polysomnography, with high specificity (85%) and high sensitivity (89%)3

 

SAFER

Advanced AV management for increased protection.2

SafeR allows for intelligent management of AV conduction, dramatically reducing unnecessary RV pacing in all pacemaker patients, including AV block patients.1,2,10,11,12,13

 

 

New Evidence - Results from the ANSWER study

The clinical benefits of SafeR were investigated during the new ANSWER study after 3-years follow-up.

SafeR is the only pacing algorithm which has been proven to strongly reduce ventricular pacing for AV block patients as well as SND patients.2,14

 

Benefits of SafeR
1. Safely manages all types of AV block1,2,15
2. Reduces RV pacing in SND and AV block patients2,13,14
3. Reduces the risk of cardiac death or HF hospitalization by 51%2
4. Adds 2 years to device longevity16

 

 

HF HOSPITALIZATION OR CARDIAC DEATH

 

KORA 250 SR & DR PACEMAKERS

 

 

REferences

  1. Sorin implant manuals (Kora 250 DR-U531 and Kora 250 SR-U532) available at sorinmanuals.com
  2. Stockburger M, Boveda S, Defaye P, Moreno J. et al.Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in general population (ANSWER study). European Heart Journal. 2015 Jan 14; 36 (3): 151-157.
  3. Defaye P, De la Cruz I, Martí-Almor J et al. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: The DREAM European study. Heart Rhythm. 2014; 11: 842-8.
  4. Sorin MRI solutions manual (Kora 250 U641) available at sorinmanuals.com.
  5. Gottlieb DJ, Yenokyan G, Newman AB et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27; 122(4):352-60.
  6. Mehra R, Benjamin EJ, Shahar E et al. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir CritCare Med. 2006 Apr 15; 173(8): 910-6.
  7. Monahan K, Brewster J, Wang L, et al. Relation of the severity of obstructive sleep apnea in response to anti-arrhythmic drugs in patients with atrial fibrillation or atrial flutter. Am J Cardiol. 2012; 110: 369-72.
  8. Kanagala R, Murali NS, Friedman PA et al. Obstructive sleep apnea and the recurrence of atrial fibrillation.Circulation. 2003 May 27; 107(20): 2589-94.
  9. Ng CY et al. Meta-analysis of obstructive sleep apnea as predictor of atrial fibrillation recurrence after catheter ablation. Am J Cardiol. 2011 Jul 1; 108(1): 47-51.
  10. Sweeney M, Hellkamp A, Ellenbogen K, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003; 107: 2932-2937.
  11. Wilkoff BL et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator(DAVID trial). JAMA. 2002; 288: 3115–23
  12. Stockburger M, Defaye P, Boveda S, et al. Physiological pacing with SafeR is safe and efficient in atrio-ventricular block and sinus node dysfunction patients – A subgroup analysis of the ANSWER trial. Abstract submitted for publication.
  13. Davy JM, Hoffmann E, Frey A et al. Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients. Pacing Clin Electrophysiol. 2012; 35(4): 392–402.
  14. Stockburger M, Defaye P, Boveda S, et al. Physiologicalpacing with SafeR is safe and efficient in atrio-ventricular block and sinus node dysfunction patients – A subgroup analysis of the ANSWER trial. Abstract submitted for publication.
  15. Stockburger M, Trautmann F, Nitardy A et al. Pacemaker-based analysis of AV conduction and atrial tachyarrhythmiasin patients with primary sinus nodedysfunction. Pacing Clin Electrophysiol. 2009; 32:604-13.
  16. Benkemoun H, Sacrez J, Lagrange P et al. Optimizing pacemaker longevity with pacing mode and settings programming: results from a pacemaker multicenter registry. Pacing Clin Electrophysiol. 2012; 35(4):403–8.

 

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