Topera Medical

Last updated
Topera, Inc.
Private
FoundedSan Diego, California
FoundersDr. Sanjiv Narayan, Ruchir Sehra
Headquarters
Palo Alto, California
Key people
Edward Kerslake CEO A
Website www.toperamedical.com

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. [1] [2] [3] 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. [2]

Contents

History

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]

Funding

The company raised $2.75 million in its seed funding round in 2012; [13] A few months later, it received an additional $3.77 million in partial close funding. [14] In May 2013, the company closed on $25 million in a C series of funding led by New Enterprise Associates. [15] [16]

Products

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]

Clinical trials

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]

Related Research Articles

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Cardiac electrophysiology science of elucidating, diagnosing, and treating the electrical activities of the heart

Cardiac electrophysiology is the science of elucidating, diagnosing, and treating the electrical activities of the heart. The term is usually used in a clinical context to describe studies of such phenomena by invasive (intracardiac) catheter recording of spontaneous activity as well as of cardiac responses to programmed electrical stimulation (PES), see Clinical cardiac electrophysiology. Cardiac electrophysiology also encompasses basic research and translational research components. Someone who studies cardiac electrophysiology, either clinically or solely through research, is known as a cardiac electrophysiologist.

Catheter ablation minimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts

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Atrial fibrillation Rapid, irregular beating of the atria of the heart

Atrial fibrillation is an abnormal heart rhythm (arrhythmia) characterized by the rapid and irregular beating of the atrial chambers of the heart. It often begins as short periods of abnormal beating, which become longer or continuous over time. It may also start as other forms of arrhythmia such as atrial flutter that then transform into AF. Often episodes have no symptoms. Occasionally there may be heart palpitations, fainting, lightheadedness, shortness of breath, or chest pain. The disease is associated with an increased risk of heart failure, dementia, and stroke. It is a type of supraventricular tachycardia.

Left atrial appendage occlusion

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The management of atrial fibrillation (AF) is focused on preventing temporary circulatory instability, stroke and other ischemic events. Control of heart rate and rhythm are principally used to achieve the former, while anticoagulation may be employed to decrease the risk of stroke. Within the context of stroke, the discipline may be referred to as stroke prevention in atrial fibrillation (SPAF). In emergencies, when circulatory collapse is imminent due to uncontrolled rapid heart rate, immediate cardioversion may be indicated.

Arrhythmia Group of conditions in which the heartbeat is irregular, too fast, or too slow

Arrhythmia, also known as cardiac arrhythmia or heart arrhythmia, is a group of conditions in which the heartbeat is irregular, too fast, or too slow. The heart rate that is too fast – above 100 beats per minute in adults – is called tachycardia, and a heart rate that is too slow – below 60 beats per minute – is called bradycardia. Some types of arrhythmias have no symptoms. Symptoms when present may include palpitations or feeling a pause between heartbeats. In more serious cases, there may be lightheadedness, passing out, shortness of breath or chest pain. While most types of arrhythmia are not serious, some predispose a person to complications such as stroke or heart failure. Others may result in sudden death.

An AF-Nest or Atrial Fibrillation Nest (AFN) is a locus or cluster in the atrial wall with distinct electrical features and properties originated by fibrillar myocardium. It plays as an "electrical multiplier" re-feeding the atrial fibrillation.

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