Technology Prevails: The Long-Awaited Transcatheter Aortic Valve Replacement Device

Technology Prevails:The Long-Awaited Transcatheter Aortic Valve Replacement Device

Maria Shepherd

Data Decision Group

The current average age for patients in the United States diagnosed with severe aortic stenosis (a type of valvular heart disease characterized by an abnormal narrowing of the aortic valve opening) is 70 years old.1Traditional valve replacement is considered a high-risk surgery for elderly patients, especially as this patient demographic usually has one, if not more, co-morbidities. Due to their condition, a significant percentage of patients diagnosed with moderate or severe valve disease have been denied traditional valve surgery, due to its high operativemortality rate.

Why This is Important

Interventional cardiologists exceptionally are enthusiastic about the potential of transcatheter aortic valve replacement, and with good reason.2 The preliminary data on this new device show that the procedure provides a minimally invasive alternative to cardiac valve surgery. Sessions at the recent 2010 EuroPCR meeting in Paris, France, were standing room only, as crowds of physicians attended to hear presentations on transcatheter aortic heart valve implantation.

The Source Registry

Dr. Martyn Thomas, cardiothoracic services director at Guy’s & St. Thomas’ Hospital in London, the United Kingdom, presented one-year results at EuroPCR from the SOURCE clinical trial for Edwards Lifesciences’ Sapien device.3The SOURCE registry included 1,038 patients (98 percent follow-up) treated in 32 hospitals and medical centers across Europe. Thirty-day and one-year survival rates for this very high-risk population are presented in Chart 1.4
 

The first transcatheter aortic valve replacement was performed in 2002. Since then, the prosthetic heart valve market has evolved at a dramatic pace. This market is extremely competitive with more than 100 products in development from more than 25 companies. There currently are two products commercially available internationally (except in the United States, where the devices haven’t yet received U.S. Food and Drug Administration [FDA] approval)—the Sapien from Edwards Life Sciences and CoreValve from Medtronic. Medtronic acquired the technology through its buyout of CoreValve Inc. in 2009 for approximately $700 million.

Both products show rapid adoption rates in spite of constrained patient exclusion criteria. The cost of these devices is high, especially by price-sensitive European standards. Device costs are reported to range from $25,000 to $35,000, compared with $2,800 to $5,600 for traditional aortic valve surgery.Estimated procedure volumes are presented in the Chart 2.5
 

The global market opportunity for transcatheter heart valves is estimated at more than 300,000 patients worldwide annually.6 While transcatheter heart valves currently are indicated only for high-risk patients, it is expected that they will be approved for use in the future for lower-risk patients as well.

Edwards received FDA approval to begin a pivotal clinical trial of its Sapien transcatheter heart valve technology. The PARTNER (Placement of AoRTic traNscatheterER valves) trial will evaluate the valve in patients with calcific aortic stenosis who are considered high-risk for conventional open-heart valve surgery. According to the company, the trial is designed for patients who might not be optimal candidates for conventional open-chest valve replacement due to the risk surgery might pose to them. The study began in 2007 and is slated to conclude in 2014. Estimated enrollment will be approximately 1,040 patients, according to ClinicalTrials.gov.

In October, Medtronic, Inc. received the green light from the FDA for its investigational device exemption application and pivotal clinical trial protocol to begin evaluating the CoreValve system for U.S. approval.Since receiving its CE Mark in Europe in March 2007, the CoreValve system has been implanted in more than 12,000 patients worldwide in more than 34 countries outside the U.S., according to Medtronic officials.

Once again, medical device technology prevails. Transcatheter valve replacement surgery has been in development for more than 20 years, but, finally, the benefit of a minimally invasive approach is showing remarkably improved patient outcomes though faster recovery time and less morbidity and mortality.

Maria Shepherd, founder of Data Decision Group, has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd can be reached at (617) 548-9892 or at

[email protected] or www.ddecisiongroup.com.

References:

1. www.cdc.gov

2. Tuzcu,E. Murat, et. al, Editorial; “SOURCE” of Enthusiasm for Transcatheter Aortic Valve Implantation, Circulation. 2010; 122: 8-10.

3. www.medicaldevicestoday.com/2010/06/europcr-highlights-tavi-set-to-continue-rampant-growth.html

4. Thomas, M. et. al. the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry, Circulation. 2010; 122: 62-69.

5. Medtech Insight, June 2010

6. Global Cardiovascular Pipeline Landscape, Jan. 2010