Cardiac Dimensions

Cardiac Dimensions
Industry Medical devices
Founded 2001
Headquarters Kirkland, Washington, United States
Number of locations
 United States, Germany, Australia
Key people
 Gregory Casciaro (president, CEO)[1][2]
Products Carillon Mitral Contour System
Website CardiacDimensions.com

Cardiac Dimensions is a multi-national medical device company founded in 2001 with offices based in Kirkland, Washington,[3] Macquarie Park, NSW, Australia,[4] and Offenbach, Germany.[3] Since its founding the company has raised significant venture funding to expand internationally and conduct clinical trials.[5][6][7][8][9] Most recently it announced a $43 million financing in March 2015[4][10] from an “international syndicate of institutional investors.”[4][11][12][13]

The company is known for The Carillon Mitral Contour System,[8] a medical device intended to treat "the most common type of heart valve disorder," called functional (secondary) mitral valve regurgitation "[which] affects how the heart properly pumps out blood."[4] A number of papers on Carillon clinical trials[14] have been published in journals such as Journal of the American College of Cardiology, American Journal of Cardiology, and BMC Cardiovascular Disorders.[15] Described by Cardiac Dimensions as the "only right-sided [venous approach] implantable device [specifically] designed... to treat FMR,"[16] the Carillon system was CE Marked for use in Europe in 2011.[17] As of late 2015, Cardiac Dimensions continues to maintain its headquarters in Kirkland, with clinical operations and research and development in Australia[4][11] and commercial operations in Germany.[3][11]

Carillon Mitral Contour System

Overview

Carillon Mitral Contour System
Product type Medical device
Produced by Cardiac Dimensions
Country United States
Introduced 2012 (Europe)
Markets Europe, Middle East
Website CardiacDimensions.com

The Carillon Mitral Contour System, also described as the Carillon device, has been the primary medical device designed and produced by Cardiac Dimensions since the company's founding in 2001.[18] The device is inserted into the coronary sinus and great cardiac vein (which run parallel to the mitral valve) using "standard cardiac catheterization techniques" as compared to open-heart surgery, and is designed to be implanted in such a way that it helps reshape the mitral valve, particularly to "reduce mitral annulus dilation."[18] By doing so, the small device is intended to "[address] a root cause of functional mitral regurgitation (FMR)."[15] It is routinely described by Cardiac Dimensions as the "only right-sided [venous approach] implantable device designed... to treat FMR."[16]

The [percutaneous Carillon technique developed by Cardiac Dimensions] allows a cardiologist to use a catheter to thread a tiny metal implantable device through a patient's jugular vein. The device wraps around a leaky heart valve in patients with [functional (secondary) mitral regurgitation or 'FMR'], tightens the loose tissue around the valve and eliminates backflow, enabling the heart to pump blood more efficiently.
— The Seattle Times, March 17, 2004[6]

Clinical trials and research

2004-2009

Cardiac Dimensions published the results of its pre-clinical trials with the Carillon therapy in the Journal of the American College of Cardiology in 2004, with the authors concluding the results were positive and showed "acute and chronic efficacy" of the device in an animal heart failure model.[19] The device was first tested in human clinical trials in 2005, with "an initial clinical trial in about 10 patients in Australia."[6] Around August 2009, the results of the Carillon Mitral Annuloplasty Device European Union Study (AMADEUS) were released, with researchers concluding "the device" is feasible in patients with heart failure, is associated with a low rate of major adverse events and an improvement in quality of life and exercise tolerance."[19] The results of the company's AMADEUS trial, which had been conducted at multiple centers, were published in August 2009 in publications such as the American Journal of Cardiology[19] and Circulation.[20] The abstract noted that the Carillon device had been approached with caution by physicians because of "the potential to compress a coronary artery," which the AMADEUS study concluded was not a significant risk.[19]

2010-2014

On May 21, 2012, the results of Cardiac Dimensions' TITAN trials were published in the European Journal of Heart Failure. Researchers concluded the device worked positively in "treating functional mitral regurgitation (FMR) in symptomatic heart failure patients," as "percutaneous reduction of FMR using [the Carillon device] is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months."[19] Data from the TITAN II study was presented in 2014, which again found positive improvement in 80% of their 30-person sample group over 12 months.[21] By the conclusion of TITAN II, around 100 patients had been involved in prospective "multi-center" trials of the Carillon Mitral Contour System.[22] In October 2014, a study on the Carillon device was published in Catheterization and Cardiovascular Interventions.[23]

2015-present

In September 2015, an independent German study analyzed data from the earlier TITAN and TITAN II trials, with the results published in BMC Cardiovascular Disorders. The researchers concluded "the Carillon Mitral Contour System is projected to be a cost-effective treatment option when compared to a typical regimen of optimal medical treatment (OMT), the present standard of care for functional mitral regurgitation (FMR)."[15]

After the AMADEUS, TITAN, and TITAN II trials, in the summer of 2015 the company announced it had opened enrollment for a new clinical trial of the Carillon System. The Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation study (REDUCE FMR) was described as a "prospective, [blinded], multi-center trial that will randomize 120 patients at up to 20 hospitals in Europe and Australia." [24] Furthermore, "all patients enrolled in the study are on an optimized heart failure medication regimen... the patients are then randomized into two groups: treatment with the Carillon device in addition to the continued medication regimen versus the continued optimized regimen of heart failure medication alone." [24] The ending date for the trial was estimated to be July 2017.[25]

Further reading

Articles
Clinical trials and papers

See also

References

  1. ↑ "Cardiac Dimensions Announces Appointment Of Gregory D. Casciaro As President And Chief Executive Officer". cardiacdimensions.com. December 15, 2015. Retrieved 2016-01-25.
  2. ↑ "Board of Directors". Cardiacdimensions.com. Retrieved 2016-01-25.
  3. 1 2 3 "Company Overview of Cardiac Dimensions". Bloomberg. Retrieved 2016-01-25.
  4. 1 2 3 4 5 Soper, Taylor (April 16, 2014). "Cardiac Dimensions raises $20M to sell heart-valve repair technology". GeekWire. Retrieved 2016-01-25.
  5. ↑ "Growth continues in nascent industry". Puget Sound Business Journal. March 16, 2005. Retrieved 2016-01-25.
  6. 1 2 3 Timmerman, Luke (March 17, 2004). "New shot of cash pumps up Cardiac Dimensions". The Seattle Times. Retrieved 2016-01-25.
  7. ↑ "Transaction Record for Cardiac Dimensions". venturedeal.com. March 17, 2004. Retrieved 2016-01-25.
  8. 1 2 Hamilton, David (December 19, 2007). "Life sciences briefing: Wednesday, Dec. 19, 2007". VentureBeat. Retrieved 2016-01-25.
  9. ↑ "Cardiac Dimensions Closes $15 Million Series C, 3/17/2004". cardiacdimensions.com. March 17, 2004. Retrieved 2016-01-25.
  10. ↑ Timmerman, Luke (September 12, 2012). "Cardiac Dimensions Nabs $5.8M for Heart Failure Device". Xconomy. Retrieved 2016-01-25.
  11. 1 2 3 Romano, Benjamin (April 16, 2014). "Rain in Seattle - Major funding for Julep-Avvo-Cardiac-Dimensions". Xconomy. Retrieved 2016-01-25.
  12. ↑ Pash, Chris (December 11, 2014). "Mark Carnegie Is Bringing New Technology To Australia -- By Raiding The American Medical Industry". Business Insider. Retrieved 2016-01-25.
  13. ↑ Keenan, Joseph (April 16, 2014). "Cardiac Dimensions raises $20M for heart valve expansion in Europe, Australia". Fierce Medical Devices. Retrieved 2016-01-25.
  14. ↑ "Cardiac Dimensions commences commercialization of CARILLON mitral contour system in Europe". News Medical. September 29, 2012. Retrieved 2016-01-25.
  15. 1 2 3 "Carillon Mitral Contour System Deemed Cost-Effective Treatment for Functional Mitral Regurgitation". dicardiology.com. September 10, 2015. Retrieved 2016-01-25.
  16. 1 2 "Sales Brochure - 2015 PDF". cardiacdimensions.com.
  17. ↑ "Cardiac Dimensions® Receives CE Mark Approval For Enhanced CARILLON® Mitral Contour System®". Cardiacdimensions.com. September 29, 2011. Retrieved 2016-01-25.
  18. 1 2 "Technology of the Carillon System". cardiacdimensions.com. Retrieved 2016-01-25.
  19. 1 2 3 4 5 "Cardiac Dimensions Publications". Cardiacdimensions.com. Retrieved 2016-01-25.
  20. ↑ "Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.". Circulation. July 28, 2009. Retrieved 2016-01-25.
  21. ↑ "Cardiac Dimensions Announces New Long-Term Outcomes Data From TITAN II Clinical Trial Demonstrates Safety, Efficacy Of Enhanced CARILLON Mitral Contour System". Cardiac Dimensions - press release. Retrieved 2016-01-25.
  22. ↑ "Cardiac Dimensions Announces New Long-Term Outcomes Data From TITAN II Clinical Trial Demonstrates Safety, Efficacy Of Enhanced CARILLON Mitral Contour System". cardiacdimensions.com. Retrieved 2016-01-25.
  23. ↑ "Restoration of normal left ventricular geometry after percutaneous mitral annuloplasty: case report and review of literature.". Catheter Cardiovascular Intervention (Wiley Periodicals). 2014. Retrieved 2016-01-25.
  24. 1 2 "Cardiac Dimensions Begins Enrollment for REDUCE FMR Trial of the CARILLON Mitral Contour System". citoday.com. June 25, 2015. Retrieved 2016-01-25.
  25. ↑ "CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation (REDUCE FMR)". Clinicaltrials.gov. May 2015. Retrieved 2016-01-25.

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