Study Shows Medtronic’s CoreValve TAVR Device Has Consistent And Cost Effective Performance

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Medtronic, Inc.‘s (NYSE: MDT) CoreValve transcatheter aortic valve replacement (TAVR) system continues to provide efficient treatment at two years for extreme-risk patients, the company announced at the ongoing Transcatheter Cardiovascular Therapeutics (TCT) 2014 Conference in Washington, D.C. Compared to a mortality rate of about 50% (at one year) for high-risk atrial fibrillation patients not undergoing treatment, patients using the CoreValve TAVR system reported a lower all-cause mortality rate of 36.5% and major stroke rate of 5.1% at the end of two years, consistent with the one-year clinical trial results of the device. TAVR therapy is used to replace impaired heart valves in patients who are too weak for traditional open heart surgery. ((CoreValve Two-Year Study-Press Release, Medtronic, Sept 13 2014))

At the conference, the company also announced that the CoreValve TAVR system was more cost-effective compared to traditional surgical aortic valve replacement (SAVR) at one year. The results were based on a number of parameters including resources used compared to procedure time, hospital length of stay, ICU time and rehab requirements post hospitalization. This was the first time that an in-trial cost effectiveness analysis for TAVR had been done for high risk patients by any company. [1]

We expect these results to help Medtronic boost sales of its CoreValve device in the U.S., especially when healthcare costs are increasingly under scrutiny. The CoreValve system received U.S. Food and Drug Administration (FDA) approval for use on patients with extreme-risk and high-risk of surgery in June, and competes with Edwards Lifesciences’ (NYSE:EW) Sapien Valve device. Statistics suggest that there are about 100,000 such patients in North America, increasing annually by about 9%. [2] Outside the U.S., CoreValve devices have been implanted in close to 65,000 patients since 2007, and it is currently a leading player in the TAVR device market in Europe. [3] [1]

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CoreValve U.S. Pivotal Trial Results

Medtronic presented two year results of its CoreValve U.S. pivotal trial for extreme risk patients at the TCT 2014 conference recently. As mentioned above, the two year results were consistent with the one year trial data of the CoreValve system, with all-cause mortality at 36.5% and major stroke chances at 5.1%. The results was also consistent in other performance parameters such as blood flow (hemodynamic) and blood flow resistance. [1]

The study continued to report low levels of paravalvular leaks (PVL), consistent with the rates reported at one year (4.4%). A paravalvular leak is a leakage of blood in the valvular region due to improper fitting of the implanted valve in the cardiac tissue. Results were also consistent for heart failure symptoms (measured by New York Heart Association (NYHA) Classification), with 92% of heart failure patients reporting an improvement by at least one class and 58% by at least two NYHA classes by the end of two years.

Cost Effectiveness Study Results

The first-ever cost effectiveness study of the CoreValve TAVR device for high-risk patients revealed that TAVR therapy had significant benefits over SAVR procedures. TAVR patients reported a procedure time of 61 +/- 35 minutes versus 221 +/- 85 minutes for SAVR, hospital length-of-stay of 8.1 days versus 12.5 days for SAVR, ICU time of 3.1 days versus 4.7 days for SAVR, and only 23% TAVR patients required rehabilitation services post discharge compared to 44% for SAVR. There was also an improvement in the Quality of Life (QoL) of TAVR patients compared to SAVR at one month. However, it was similar at longer time frames of 6 months and one year. [2]

In terms of costs, the initial per patient cost of TAVR therapy was higher than SAVR by about $11,000, which did not fully offset the savings due to the aforementioned benefits such as shorter hospital stays. However, TAVR added 0.24 life years and 0.20 quality-adjusted life years (QALY) per patient. At an incremental cost effectiveness ratio (ICER) of $57,000 per life year gained, this reflects a lifetime incremental cost of about $13,700 for the CoreValve system. Dr. Matthew Reynolds, who presented the findings at TCT 2014, said that the higher cost of TAVR was in a range considered acceptable in the U.S., with the procedure being cheaper than dialysis but slightly expensive than atrial fibrillation ablation. [4]

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Notes:
  1. Cost Effectiveness-Press Release, Medtronic, Sept 13 2014 [] [] []
  2. Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement, Medscape, 2013 [] []
  3. FDA Approves Medtronic’s CoreValve; Device Available Immediately in U.S., Angioplasty.org, Jan 17 2014 []
  4. No Deaths With Mild/Moderate Paravalvular Leaks: CoreValve Extreme Risk at Two Years, Medscape, September 14 2014 []