Vanguard sets the standard in medical remanufacturing of EP catheters

With the remanufacture of cooled ablation and 3D mapping catheters – Vanguard AG is taking medical remanufacturing of disposable medical products to a whole new level.

Treating atrial fibrillation

In atrial fibrillation, faulty electrical impulses throw the heart out of rhythm and the heart beats irregularly.

Coronary heart disease (atrial fibrillation) is the most common form of cardiac arrhythmia (irregular heartbeat) in adults worldwide. The lifetime risk for a 55-year-old European is between 35% and 40%. The risk of stroke is particularly high. In addition to increasing age, risk factors include (common) diseases such as high blood pressure, obesity, diabetes mellitus and frequent pauses in breathing at night.

In many cases, the occurrence of atrial fibrillation is triggered by extra electrical impulses from the pulmonary veins. This results in irregular electrical activity in the atria, which leads to an irregular and often too fast heartbeat. This leads to structural changes in the atria, which in turn favours the occurrence of atrial fibrillation.

If anticoagulant medication does not have the desired effect or is not an option, the heart can be successfully treated with catheter ablation, for example (see ESC guidelines, German Heart Foundation). Catheter ablation is now the treatment of choice for patients with atrial fibrillation who cannot be treated with medication to eliminate attacks or symptoms. The most important aim is to normalise electrical signals, restore the normal heart rhythm and thus prevent strokes.

With Vanguard’s restored catheters, the treatment of atrial fibrillation is sustainable, economical and safe.

The remanufactured medical devices from our electrophysiology portfolio meet all the needs of cardiac diagnostic and ablation procedures. You will not notice any difference between the remanufactured and original products when performing ablation procedures to treat abnormal heart rhythms. The patient will not feel the difference either.

Diagnosis and treatment of atrial fibrillation with 3D mapping

In minimally invasive catheter ablation, a catheter is (usually) advanced from the groin through the great vena cava to the heart.

The most commonly used method for isolating the pulmonary veins is point-by-point radiofrequency current ablation, which leads to cell necrosis through tissue heating. As the ablation catheter is controlled via electroanatomical mapping, this technique requires less radiation, but the examination is complex and can take longer. Another increasingly promising method is ablation with cold energy. The doctor scleroses a very specific area in the left atrium using high-frequency current or alternatively using cold (cryoballoon ablation). In both cases, this means that interference impulses can no longer reach the left atrium from this area – the area around the mouth of the four pulmonary veins – and trigger atrial fibrillation.

The success rate after one year with this method is 60 to 80 per cent, and around 90 per cent after a repeat procedure.

With the catheters for cardiac mapping systems, e.g. from Biosense Webster or Abbott, electrophysiologists can create a map of the heart, as with the original product, and thus obtain a clear picture of the electrical signals that control the heart rhythms. Once a map is created, doctors can identify electrical disturbances and areas of the heart that are causing heart rhythm problems and use ablation to treat the problem, such as atrial fibrillation. Cardiac ablation is a minimally invasive procedure to treat abnormally fast heartbeats. It involves creating lesions (ablations) in small areas of heart tissue that a doctor has identified as the cause of the arrhythmia.

Treatment options – Vanguard’s state of the art portfolio

Abbott’s EnSite Precision System or Biosense Webster’s Carto3 System have advanced imaging capabilities that enable real-time visualisation of a three-dimensional (3D) model of the patient’s cardiac anatomy. This allows physicians to more accurately identify areas of the heart that require ablation. The high-resolution cardiac mapping capability offered by these systems helps to quickly and accurately capture data and diagnose arrhythmias.

With Vanguard’s remanufactured catheters for the EnSite Precision System, physicians can opt for traditional impedance measurement (using mechanical cardiac activity) or electromagnetic technology, which enables precise localisation of the sensor-enabled catheters during treatment, as with the original product.

Biosense Webster is the industry leader in the diagnosis and treatment of cardiac arrhythmias. The Carto3 system is the most advanced three-dimensional imaging system for the electrophysiological treatment of cardiac arrhythmias. Even with the reprocessed catheters for the Carto3 system, the treatment of cardiac arrhythmias is just as fast and precise as with the original product, from the signals through diagnosis to a wide range of electrophysiological procedures.

You can also take advantage of Vanguard’s Clinical Support. Because atrial fibrillation is one of the most common heart diseases, our Clinical Support enables you to act independently of the original manufacturer in the long term. Vanguard’s Clinical Support has many years of experience in performing diagnostic cardiac catheterisations and ablations and also accompanies demanding procedures. In addition, we offer you intensive coaching and workshops for assistant doctors and nursing staff so that you can not only perform procedures for atrial fibrillation, but also procedures for other arrhythmias independently.

Vanguard: Experts in their field

Microbiological Testing

Ensuring the effectiveness of the cleaning process by testing for protein residues on each catheter using the modificated OPA method, reference method according to ISO 15883 and the in-house L2 hygiene laboratory all including documentation.