|Founded||San Diego, California|
|Founders||Dr. Sanjiv Narayan, Ruchir Sehra|
Palo Alto, California
|Edward Kerslake CEO A|
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.
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.
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 presented at the Heart Rhythm Society's 2012 scientific sessions in Boston, Massachusetts.
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 company closed on $25 million in a C series of funding led by New Enterprise Associates.
Topera developed a 3D mapping tool 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 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.
The Focal Impulse and Rotor Modulation procedure decreases procedure times and reduces re-ablation rates by targeting the source of arrhythmia.
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.
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.
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.
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%.
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.
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%.
A cardiac pacemaker, is a medical device that generates electrical impulses delivered by electrodes to cause the heart muscle chambers to contract and therefore pump blood; by doing so this device replaces and/or regulates the function of the electrical conduction system of the heart.
Wolff–Parkinson–White syndrome (WPWS) is a disorder due to a specific type of problem with the electrical system of the heart which has resulted in symptoms. About 40% of people with the electrical problem never develop symptoms. Symptoms can include an abnormally fast heartbeat, palpitations, shortness of breath, lightheadedness, or syncope. Rarely, cardiac arrest may occur. The most common type of irregular heartbeat that occurs is known as paroxysmal supraventricular tachycardia.
Atrial flutter (AFL) is a common abnormal heart rhythm that starts in the atrial chambers of the heart. When it first occurs, it is usually associated with a fast heart rate and is classified as a type of supraventricular tachycardia. Atrial flutter is characterized by a sudden-onset (usually) regular abnormal heart rhythm on an electrocardiogram (ECG) in which the heart rate is fast. Symptoms may include a feeling of the heart beating too fast, too hard, or skipping beats, chest discomfort, difficulty breathing, a feeling as if one's stomach has dropped, a feeling of being light-headed, or loss of consciousness.
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 is a procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome. If not controlled, such arrhythmias increase the risk of ventricular fibrillation and sudden cardiac arrest. The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.
Radiofrequency ablation (RFA), also called fulguration, is a medical procedure in which part of the electrical conduction system of the heart, tumor or other dysfunctional tissue is ablated using the heat generated from medium frequency alternating current. RFA is generally conducted in the outpatient setting, using either local anesthetics or conscious sedation anesthesia. When it is delivered via catheter, it is called radiofrequency catheter ablation.
Tachycardia-induced cardiomyopathy (TIC) is a disease where prolonged tachycardia or arrhythmia causes an impairment of the myocardium, which can result in heart failure. People with TIC may have symptoms associated with heart failure and/or symptoms related to the tachycardia or arrhythmia. Though atrial fibrillation is the most common cause of TIC, several tachycardias and arrhythmias have been associated with the disease.
The mini-maze procedures are cardiac surgery procedures intended to cure atrial fibrillation (AF), a common disturbance of heart rhythm. They are procedures derived from the original maze procedure developed by James Cox, MD.
Dronedarone is a drug by Sanofi-Aventis, mainly for the indication of cardiac arrhythmias. It was approved by the FDA on July 2, 2009. It was recommended as an alternative to amiodarone for the treatment of atrial fibrillation and atrial flutter in people whose hearts have either returned to normal rhythm or who undergo drug therapy or electric shock treatment i.e. direct current cardioversion (DCCV) to maintain normal rhythm. It is a class III antiarrhythmic drug. In the United States, the FDA approved label includes a claim for reducing hospitalization, but not for reducing mortality, as a reduction in mortality was not demonstrated in the clinical development program. A trial of the drug in heart failure was stopped as an interim analysis showed a possible increase in heart failure deaths, in patients with moderate to severe CHF.
The CHADS2 score and its updated version, the CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy, since AF can cause stasis of blood in the upper heart chambers, leading to the formation of a mural thrombus that can dislodge into the blood flow, reach the brain, cut off supply to the brain, and cause a stroke.
Michel Haïssaguerre is a French cardiac electrophysiologist.
The Sensei X robotic catheter is a medical robot designed to enhance a physician’s ability to perform complex operations using a small flexible tube called a catheter. As open surgical procedures that require large incisions have given way to minimally invasive surgeries in which the surgeon gains access to the target organs through small incisions using specialized surgical tools. One important tool used in many of these procedures is a catheter used to deliver many of things a surgeon needs to do his work, to impact target tissue and deliver a variety of medicines or disinfecting agents to treat disease or infection.
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 (LAAO), also referred to as Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).
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, 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.
Yaariv Khaykin is a Canadian cardiologist and a clinical researcher in the area of electrophysiology. He is the director of the Newmarket Electrophysiology Research Group at the Southlake Regional Health Centre. He has published research into complex ablation and pioneered cardiac ablation methods.
Robotic magnetic navigation (RMN) uses robotic technology to direct magnetic fields which control the movement of magnetic-tipped endovascular catheters into and through the chambers of the heart during cardiac catheterization procedures.
Bruce B. Lerman is a cardiologist. He is the Hilda Altschul Master Professor of Medicine at Weill Cornell Medical College, and Chief of the Division of Cardiology and Director of the Cardiac Electrophysiology Laboratory at Weill Cornell Medicine and the New York Presbyterian Hospital.