Facts About Ablacor's AF Catheter Ablation System

Facts About Ablacor's AF Catheter Ablation System

Continuous tissue contact for precise lesion formation the first time

AblaCor's AF Ablation Catheter
AblaCor's AF Ablation Catheter

Endorsed by prominent physicians, AblaCor's AF Catheter Ablation System is an innovative ‘single-shot’ radiofrequency (RF) ablation system. The system addresses physicians’ unmet needs to effectively treat atrial fibrillation (AFib) and reduce the number of repeat procedures for pulmonary vein isolation (PVI). Unique from other ablation technologies, Ablacor's catheter offers anchor stabilization at the point of electrode-tissue contact. This will provide durable ablation lesions and a permanent PVI the first time. This includes a strong patent portfolio for the technology.

Features and Benefits

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Unique flow-through anchor and discrete electrode array

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The anchor stabilizes the electrode array for optimum tissue contact around the PV

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Consistent tissue contact yields precise energy delivery for continuous, durable lesion creation in a single procedure

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Ablation and feedback capabilities all in one catheter

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Feedback helps the physician verify lesion quality

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​How AFib is treated today

Two of the more commonly used treatments for AFib are the destruction of tissue by burning with various energy sources or freezing. Current ablation catheter systems consist primarily of either “point-by-point” or “balloon” devices. The ablation procedure, called pulmonary vein isolation (PVI), creates a lesion (scar tissue) to block abnormal electrical signals from passing from the pulmonary veins (PV) to the atria in the beating heart. This is accomplished by generating continuous, long-lasting, transmural (through the heart wall) lesions around the PVs. A successful PVI reduces or eliminates the burden of AFib for patients. 

Recurrent AFib observed in 30% of patients after procedures with current technologies

Current ablation technologies frequently fail to maintain conduction block after ablation treatment. This is often caused by gaps in the lesions. Irregular electrical signals can travel from the PVs through the gaps into the left atrium, causing electrical reconnection of the PVs and recurrence of AFib.

Current devices do not consistently stabilize the ablation catheter against the heart tissue around the PVs, requiring the physician to manually apply contact during the ablation cycle. Making this even more complicated, the procedure is performed in the beating heart. Thirty percent of patients have recurrence of AFib within the first year after ablation.

Designed to be superior to current devices

The catheter is designed to offer a durable (long-term) solution to PVI ablation. The table to the right shows how the “single-shot” catheter is unique from current “point-by-point” and "balloon" ablation devices.

Anchor Stabilizes electrode-tissue contact
Precise, controlled energy delivery
Consistent lesions encircling PVs

About ​AFib

Special cells in the heart create electrical signals that travel along pathways to the chambers of the heart. These signals make the heart’s upper and lower chambers beat in the proper sequence. Abnormal cells may create disorganized electrical signals that cause irregular or rapid heartbeats called arrhythmias. The most common irregular heartbeat, and potentially deadly disorder, is called atrial fibrillation or AFib.

AFib is associated with a five-fold increased risk for stroke and an increased risk for congestive heart failure, left ventricular dysfunction, and cardiovascular hospitalizations; and a two-fold increase in mortality.

AFib often feels like a fluttering or "butterflies" in the</br> chest.  Some people with AFib have no symptoms at all.
AFib often feels like a fluttering or "butterflies" in the
chest. Some people with AFib have no symptoms at all.

It is estimated that 30 million individuals worldwide have been diagnosed with AFib, and annually more than 300,000 receive an ablation procedure to block these electrical impulses. Of those, many will need to have multiple ablation procedures. The total cost of treating AFib was $24 billion in the U.S. in 2014.

AFib is associated with other diseases such as myocardial infarction, heart valve disease, hypertension, infection, and sleep apnea. Patients with AFib can have palpitations, chest discomfort, weakness, fainting, breathlessness, fatigue and sometimes no symptoms at all. The burden of AFib can significantly affect the quality of life for patients by limiting their ability to work and play. ​

Successful outcomes with AblaCor's system will improve quality of life for individuals with AFib and significantly reduce costs associated with treatment.​

The AF Catheter Ablation System is not approved for human use