Economics of devices.

BACKGROUND

The economics of devices used for mechanical circulatory support not only involve the patient, the provider, and society as a whole, but also, importantly, the developers and manufacturers of these new technologies. The combined effects of years of development and testing with significant regulatory, reimbursement, and acceptance barriers make this a capital-intensive and high-risk endeavor. In addition, long-term circulatory support is, today, essentially limited to bridge to transplantation, a "market" of only $100 million. Competition is increasing, with new devices under development and entering clinical trials.

CONCLUSIONS

Economic health for this new industry is dependent on expanding clinical indications to definitive or destination therapy, and perhaps other applications such as bridge to recovery and assisted medical therapies.