Topera Medical

Topera, Inc.
Private
Founded San Diego, California
Founders Dr. 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]

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]

References

  1. ↑ "Topera Medical's 3rd Generation Cardiac Mapping System Gets FDA OK". med Gadget. Retrieved 15 April 2014.
  2. 1 2 3 "Topera Medical – 2013 Fierce 15". Fierce Medical Devices. Retrieved 15 April 2014.
  3. 1 2 "Company Overview of Topera, Inc.". Bloomberg Businessweek. Retrieved 15 April 2014.
  4. 1 2 "Topera quietly raises funds for heart technology". Boston.com. Retrieved 15 April 2014.
  5. ↑ "At HRS, Topera Topples Conventional Wisdom About Atrial Fibrillation". Medical Advice Today. Retrieved 15 April 2014.
  6. 1 2 3 4 Ryan McBride. "Former Boston Scientific Exec and UCSD Physician Team Up at Startup Topera Medical". Xconomy. Retrieved 15 April 2014.
  7. ↑ Bruce V. Bigelow. "Topera Maps Abnormal Currents of the Heart, Novalar Plans Shutdown, New Verenium CEO Drafts Strategy, & More San Diego Life Sciences News". Xconomy. Retrieved 15 April 2014.
  8. 1 2 Justin Klein, MD, JD. "Topera Medical: The Legend of Sanjiv Narayan". NEA. Retrieved 15 April 2014.
  9. ↑ "Topera Medical hires former Boston Scientific VP, opens Beantown HQ". Mass Device. Retrieved 15 April 2014.
  10. ↑ "Topera Medical Announces Creation of Management Advisory Board". Reuters. Retrieved 15 April 2014.
  11. ↑ "Topera Medical`s FDA-Cleared RhythmViewTM System Featured in 16 Presentations at Heart Rhythm Society 2012 Scientific Sessions". Reuters. Retrieved 15 April 2014.
  12. ↑ "Topera Medical; Topera Medical's FDA-Cleared RhythmView(TM) System Featured in Eight Presentations at the 2012 Scientific Sessions of the American Heart Association". Obesity, Fitness & Wellness Week. 17 November 2012.
  13. ↑ "Form D". United States Securities and Exchange Commission. Retrieved 15 April 2014.
  14. ↑ "Form D". United States Securities and Exchange Commission. Retrieved 15 April 2014.
  15. ↑ Bruce V. Bigelow. "San Diego Life Sciences Roundup: Topera, Afraxis, Trovagene, & More". Xconomy. Retrieved 15 April 2014.
  16. ↑ Meghana Keshavan. "Topera Collects $25M in Series C Funding". San Diego Business Journal. Retrieved 15 April 2014.
  17. 1 2 "Topera receives FDA clearance for FIRMap Catheter". News Medical. Retrieved 15 April 2014.
  18. ↑ "Topera's FIRMap Catheter Receives 510(k) Clearance". Business Monitor. Retrieved 15 April 2014.
  19. 1 2 3 4 5 Nishey Wanchoo. "Topera FIRMap Diagnostic Cardiac Catheter Wins FDA Approval". med Gadget. Retrieved 15 April 2014.
  20. 1 2 3 Haley David; Rory Lubner. "Despite FDA clearance, FIRM ablation's impact still unknown". The Advisory Board Company. Retrieved 15 April 2014.
  21. ↑ "St. Luke's first in Texas to use FDA-Cleared FIRMap Catheter". Your Houston News. Retrieved 15 April 2014.
  22. ↑ "Major Advance in AF Ablation Now Available" (PDF). Arrhythmia News. Retrieved 15 April 2014.
  23. ↑ Chris Kaiser. "HRS: Mapping Tool Boosts Afib Ablation Outcomes". medpage Today. Retrieved 15 April 2014.
  24. 1 2 3 Narayan SM; Krummen DE; Clopton P; Shivkumar K; Miller JM (2013). "Direct of Coincidental Elimination of Stable Rotors or Focal Sources May Explain Successful AF Ablation: On-Treatment Analysis of the CONFIRM Trial". 60 (2). J Am Coll Cardiol: 138–147.
  25. 1 2 Miller JM; Krummen DE; Narayan SM (Nov 2013). "Multicenter Validation of Focal Impulse and Rotor Modulation (FIRM) Ablation for Atrial Fibrillation (CONFIRM- Multicenter Validation)". AHA Scientific Sessions.
  26. ↑ Narayan SM; Baykaner T; Clopton P. "Ablation of Rotor and Focal Sources Reduces Late Recurrence of Atrial Fibrillation Compared to Trigger Ablation Alone". J Am Coll Cardiol 2014.
  27. ↑ Swarup V. "Stable Atrial Fibrillation Rotors and Focal Sources Lie in Diverse Bi-Atrial Locations Often Remote from the Pulmonary Veins". Heart Rhythm 2013.
  28. ↑ Baykaner T; Clopton P; Lalani G; Schricker AA; Krummen DE; Narayan SM (2013). "Targeted Ablation at Stable Atrial Fibrillation Sources Improves Success Over Conventional Ablation In High Risk Patients: A Substudy of the CONFIRM Trial". 29. Canadian J Cardiology: 1218–1226.
  29. ↑ Arshad A; Mittal S; Musat D. "Long-Term Success From FIRM Ablation is Maintained Even if Acute Endpoint is Not Achieved". Heart Rhythm 2013.
  30. ↑ Letsas KP; Weber R; Bürkle G; Mihas CC; Minners J; Kalusche D; Arentz T (2009). "Pre-ablative predictors of atrial fibrillation recurrence following pulmonary vein isolation: the potential role of inflammation". 11. Europace: 158–163.
  31. ↑ Hoyer FF; Lickfett LM; Mittmann-Braun E; Ruland C; Kreuz J; Pabst S; Schrickel J; Juergens U; Tasci S; Nickenig G; Skowasch D (2010). "High prevalence of obstructive sleep apnea in patients with resistant paroxysmal atrial fibrillation after pulmonary vein isolation". 29. J Interv Card Electrophysiol: 37–41.
  32. ↑ Cha YM; Friedman PA; Asirvatham SJ; Shen WK; Munger TM; Rea RF; Brady PA; Jahangir A; Monahan KH; Hodge DO; Meverden RA; Gersh BJ; Hammill SC; Packer DL (2008). "Catheter ablation for atrial fibrillation in patients with obesity". 117. Circulation: 2583–2590.
  33. ↑ Chilukuri K; Dalal D; Gadrey S; Marine JE; Macpherson E; Henrikson CA; Cheng A; Nazarian S; Sinha S; Spragg D; Berger R; Calkins H (2010). "A prospective study evaluating the role of obesity and obstructive sleep apnea for outcomes after catheter ablation of atrial fibrillation". 21. J Cardiovasc Electrophysiol: 521–525.
  34. ↑ Lin KJ; Cho SI; Tiwari N; Bergman M; Kizer JR; Palma EC; Taub CC (2009). "Metabolic syndrome and risk of recurrence of atrial fibrillation after catheter ablation". 73. Circ J: 438–443.
  35. ↑ Letsas KP; Siklódy CH; Korantzopoulos P; Weber R; Bürkle G; Mihas CC; Kalusche D; Arentz T (2011). "The impact of body mass index on the efficacy and safety of catheter ablation of atrial fibrillation". 164 (1). Int J Cardiol: 94–98.
  36. ↑ Jongnarangsin K; Chugh A; Good E; Mukerji S; Dey S; Crawford T; Sarrazin JF; Kuhne M; Chalfoun N; Wells D; Boonyapisit W; Pelosi F Jr; Bogun F; Morady F (2008). "Oral H Body mass index, obstructive sleep apnea, and outcomes of catheter ablation of atrial fibrillation". 19. J Cardiovasc Electrophysiol: 668–672.
  37. ↑ Maria Matiello; Mercé Nadal; David Tamborero; Antonio Berruezo; Josep Montserrat; Cristina Embid; Jose Rios; Julián Villacastín; Josep Brugada; Lluís Mont (2010). "Low efficacy of atrial fibrillation ablation in severe obstructive sleep apnea patients". 12. Europace: 1084–1089.
  38. ↑ Mohanty S; Mohanty P; Di Biase L; Bai R; Pump A; Santangeli P; Burkhardt D; Gallinghouse JG; Horton R; Sanchez JE; Bailey S; Zagrodzky J; Natale A (2012). "Impact of Metabolic Syndrome on Procedural Outcomes in Patients with Atrial Fibrillation Undergoing Catheter Ablation". 59 (14). J Am Coll Cardiol: 1295–1301.
  39. ↑ Tina Baykaner; Paul Clopton; Gautam G. Lalani; Amir A. Schricker; David E. Krummen; Sanjiv M. Narayan (2013). "Targeted Ablation at Stable Atrial Fibrillation Sources Improves Success Over Conventional Ablation in High-Risk Patients: A Substudy of the CONFIRM Trial". Canadian Journal of Cardiology: 1218–1226. Retrieved 15 April 2014.
  40. ↑ Narayan SM; Krummen DE; Shivkumar K; Clopton P; Rappel WJ; Miller JM (12 August 2012). "Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial.". 60 (7). J Am Coll Cardiol: 628–36. doi:10.1016/j.jacc.2012.05.022. PMC 3416917Freely accessible. PMID 22818076.
  41. ↑ Narayan SM; Krummen DE; Donsky A. "Precise Rotor Elimination without Concomitant pulmonary vein Isolation for the Successful Elimination of Paroxysmal Atrial Fibrillation". Heart Rhythm 2013.
  42. ↑ Narayan SM; Baykaner T; Krummen D. "FIRM Ablation at Rotors and Focal Sources Has Similarly High Efficacy for Paroxysmal and Persistent Atrial Fibrillation". 61 (10). JACC 2013.
  43. ↑ Cheema A; Vasamreddy CR; Dalal D. "Long-term single procedure efficacy of catheter ablation of atrial fibrillation". 15. J Interv Card Electrophysiol 2006: 145–155.
  44. ↑ Weerasooriya R; Khairy P; Litalien J; Macle L; Hocini M; Sacher F; Lellouche N; Knecht S; Wright M; Nault I; Miyazaki S; Scavee C; Clementy J; Haissaguerre M; Jais P (11 January 2011). "Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up?". J Am Coll Cardiol. pp. 160–6. Retrieved 15 April 2014.
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