Topera Medical

In 2010, Dr. Sanjiv Narayan and Dr. Ruchir Sehra founded Topera in San Diego, California .[3][4][5] Narayan founded the company to commercialize the technology he developed which maps irregular heartbeats.[6][7] Prior to founding the company, he had collected cardiac electrophysiological data from patients and wrote software to code and analyze collected data.[8] 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.[8] 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.[6]

In 2011, Topera opened an office in Lexington, Massachusetts.[6][9] Edward Kerslake, former corporate vice president of Boston Scientific became the CEO of Topera in 2010.[6] In 2011, the firm created a management advisory board.[10]

In 2012, the FDA cleared Topera's 3D mapping and analysis system, RhythmView. The system was presented at the Heart Rhythm Society's 2012 scientific sessions in Boston, Massachusetts.[11][12]

Topera developed a 3D mapping tool to assists physicians in identifying the electrical source of complex cardiac arrhythmias.[4] The FIRMap catheter, used with the RhythmView workstation, received CE clearance and FDA clearance in 2013.[17][18][19][20] 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 the contours of the heart chambers and creating a panoramic map of the electrical heart activity.[19][20] This information is sent to the workstation and creates a near real-time 3D reconstruction of the heart and its electrophysiological activity.[19] The data from the workstation is used to help diagnose the source of atrial fibrillation, atrial flutter, and atrial tachycardia and ventricular tachycardia.[2][19][21]

Prior to the company's FIRMap catheter being commercially available, the workstation was compatible with other multi-polar mapping catheters.[17][19]

The Focal Impulse and Rotor Modulation procedure decreases procedure times and reduces re-ablation rates by targeting the source of arrhythmia.[20][22]

Narayan and six other independent clinical investigators performed clinical trials that followed post-ablation procedure patients for a year. Published as a comprehensive study in August 2012, the trials showed 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. Long-term success was achieved in 82 percent of patients with a single FIRM procedure.[23]

Ten centers reported that Topera Medical's FIRM mapping system identifies patient specific sources of atrial fibrillation (rotors), and that ablation of the rotors improves treatment success with a single procedure.[24]

A second, broader clinical study at ten centers independently confirmed the findings of the first study with a success rate of 80.5% where FIRM was used.[25]

The first and second set of trials reported success after the patients were followed for one year. At the beginning of 2014, three-year results showed a success rate of 78% compared to the traditional PVI success rate of 39%.[26]

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.[24][27] 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.[28][29][30][31][32][33][34][35][36][37][38]

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.[24][25][39][40][41][42][43] 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%.[44]