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Topera, Inc. is a cardiac arrhythmia mapping company for targeting catheter ablation company launched in San Diego, California and specializes in mapping electrical signals of the heart. Topera's headquarters are located in Palo Alto, California. The company uses 3D analysis and mapping to detect the sources of atrial fibrillation, atrial flutter, and atrial tachycardia and ventricular tachycardia to identify targets for catheter ablation.

History
In 2010, Dr. Sanjiv Narayan and Dr. Ruchir Sehra founded Topera in San Diego, California. Narayan founded the company to commercialize the technology he developed which maps irregular heartbeats. Prior to founding the company, he had collected cardiac electrophysiological data from patients and wrote software to code and analyze collected data. He conducted clinical studies to prove that conventional pulmonary vein isolation (PVI) plus targeting and ablating rotors and focal impulses would increase the success rate of single procedure atrial fibrillation ablations. His training includes a master's degree in software engineering, a clinical fellowship at Harvard Medical School, and a position as a faculty tutor for the Harvard-MIT Division of Health Sciences and Technology program. Narayan is an internationally recognized cardiac electro-physiologist.

In 2011, Topera opened an office in Lexington, Massachusetts.

Edward Kerslake, former corporate vice president of Boston Scientific became the CEO of Topera in 2010. In 2011, the firm created a management advisory board.

In 2012, the FDA cleared Topera's 3D mapping and analysis system, RhythmView. The system was featured in 16 presentations at the Heart Rhythm Society's 2012 scientific sessions in Boston, Massachusetts.

Funding
The company raised $2.75 million in its seed funding round in 2012; A few months later, it received an additional $3.77 million in partial close funding. In May 2013, the it closed on $25 million in a C series of funding led by New Enterprise Associates.

Products
Topera has developed a 3D mapping and analysis system which aims to assists physicians in identifying the electrical source of complex cardiac arrhythmias. The FIRMap catheter, used with the RhythmView workstation, received CE clearance and FDA clearance in 2013. The tip of the catheter has a spherical wire basket that has 64 evenly placed electrodes over the 8 splines that make up the basket. The basket expands,  capturing all the contours of the heart chambers and creating a panoramic map of the electrical heart activity. This information is sent to the workstation and creates a near real-time 3D reconstruction of the heart and its electrophysiological activity. The data from the workstation is used to help diagnose the source of atrial fibrillation, atrial flutter, and atrial tachycardia and ventricular tachycardia.

Prior to the company's FIRMap catheter being commercially available, the workstation was compatible with other multi-polar mapping catheters. By November 2013, it was successfully used in almost 400 cases.

The FIRM (Focal Impulse and Rotor Modulation) procedure aims to decrease procedure times and reduce re-ablation rates by targeting the source of arrhythmia.

CONFIRM Trial
Dr. Sanjiv Narayan performed a clinical trial named the CONFIRM (Conventional Ablation for Atrial Fibrillation with or without Focal Impulse and Rotor Modulation) Trial with six other independent clinical investigators in 2011.

The results of the CONFIRM Trial were published in August 2012. In the trial, post-ablation procedure patients were monitored for a year, after which the researchers reported that 88 percent of the patients in the trial who received the FIRM (Focal Impulse and Rotor Modulation) procedure had a successful termination or slowing of their atrial fibrillation, and long-term success was achieved in 82 percent of patients with a single FIRM procedure.

Published data
Ten centers have reported that Topera Medical's FIRM mapping system accurately identifies patient specific sources of atrial fibrillation (rotors), and that ablation of the rotors improves treatment success with a single procedure.

A second clinical study of ten centers independently confirmed the findings of the first study with a success rate of 80.5% when FIRM was utilized.

In these previous studies, ablation success was reported after the patients were followed for 1 year. At the beginning of 2014, longer term results (3 years) were published, which showed that the FIRM results are durable over a period of several years (the FIRM success rate was 78% at 3 years, while the traditional PVI success rate was 39%).

Other published studies have shown that rotors are located in both atria of the heart and in locations that are not targeted and ablated in traditional procedures. Eliminating rotors increases success rates, even in patients with whom traditional techniques are less successful because of pre-existing conditions such as persistent atrial fibrillation, obstructive sleep apnea, metabolic syndrome, or body mass index.

Interpretation of published data
Published studies reporting success rates with Topera's FIRM-guided ablations are based on single procedure results, while other published reports reflect the outcome of multiple ablation procedures. For this reason it is difficult to compare relative success rates. One study reported success rates after a single, as well as those after multiple, procedures. The cumulative long-term success after a mean of 2 procedures was 63% while long-term success after single-procedure was only 29%.

There are published reports arguing for tracking single-procedure results because each additional procedure comes with the risk of complication and the resulting cost to the patient and healthcare system. There is an 82.4% single-procedure success rate reported for FIRM procedures while conventional PVI ablation success rates range from approximately 26% to 58%, with most patients in these studies having paroxysmal atrial fibrillation. Ablation success rates for paroxysmal atrial fibrillation are typically higher than persistent forms of atrial fibrillation.