One method for the treatment of atrial fibrillation (AF) is pulmonary vein isolation (PVI) ablation, where tissue around the connections between the left atrium and the pulmonary veins is ablated. This tissue is commonly responsible for creating and propagating the irregular signals that disrupt normal heart rhythms in AF. During this procedure, a point ablation catheter uses radio-frequency energy to create lesions in the tissue, which normalize these irregular signals. However, since point ablation catheters are difficult to position against the tissue within a beating heart and also leave gaps of intact tissue between the lesions, approximately 40% of cases will require a second ablation procedure in order to effectively treat AF.
Ablacor Medical Corp. (Needham, MA) is developing a solution to this issue with their CircumBlator catheter. It includes an anchor that sits in the pulmonary vein in order to give the operator more stability, as well as a circumferential array of electrodes (called the “umbrella ablator”) that creates a line of ablated tissue with no gaps. Additionally, it has force sensors in both the anchor and the umbrella ablator to provide feedback that the required contact with the tissue is achieved. Not only does this lead to more successful procedures but also faster procedures that can be performed by less skilled operators.
Ablacor has built a successful prototype and demonstrated proof-of-concept on animal tissue. Their next steps include applying for a CE mark and beginning to collect clinical data for an FDA submission.