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Introduction of emerging medical devices on the market: A new procedure in Belgium

Published online by Cambridge University Press:  01 October 2007

Imgard Vinck ,
Mattias Neyt ,
Nancy Thiry ,
Marleen Louagie  and
Dirk Ramaekers
Imgard Vinck
Affiliation:
Belgian Health Care Knowledge Centre
Mattias Neyt
Affiliation:
Belgian Health Care Knowledge Centre
Nancy Thiry
Affiliation:
Belgian Health Care Knowledge Centre
Marleen Louagie
Affiliation:
National Health Insurance Institute
Dirk Ramaekers
Affiliation:
Belgian Health Care Knowledge Centre
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Abstract

When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost-effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre.

Keywords

Equipment and suppliesTechnology assessmentBiomedicalEvidence-based medicineReimbursement mechanisms
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 23 , Issue 4 , October 2007 , pp. 449 - 454
Copyright
Copyright © Cambridge University Press 2007

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References

REFERENCES

1.Blankensteijn, JD, de Jong, SE, Prinssen, M, et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005;352:2398–2405.CrossRefGoogle ScholarPubMed
2.European Council. Council Directive on the approximation of the laws of the Member States relating to active implantable medical devices. 1990. L 189 20 July 1990: 90/385/EEC.Google Scholar
3.European Council. Council Directive concerning medical devices. 1993. L 169 12 July 1993: 93/42/EEC.Google Scholar
4.European Council. Council Directive on in vitro diagnostic medical devices. 1998. L 331 7 December 1998: 98/79/EC.Google Scholar
5.EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): Randomised controlled trial. Lancet. 2005;365:2179–2186.CrossRefGoogle Scholar
6.Greenhalgh, RM, Brown, LC, Kwong, GP, et al. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: Randomised controlled trial. Lancet. 2004;364:843–848.CrossRefGoogle ScholarPubMed
7.Mas, JL, Chatellier, G, Beyssen, B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660–1671.CrossRefGoogle ScholarPubMed
8.Prinssen, M, Buskens, E, Blankensteijn, JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods. J Cardiovasc Surg (Torino). 2002;43:379–384.Google ScholarPubMed
9.Prinssen, M, Buskens, E, Blankensteijn, JD, DREAM trial participants. Quality of life endovascular and open AAA repair. Results of a randomised trial. Eur J Vasc Endovasc Surg. 2004;27:121–127.CrossRefGoogle ScholarPubMed
10.Prinssen, M, Buskens, E, Nolthenius, RP, et al. Sexual dysfunction after conventional and endovascular AAA repair: Results of the DREAM trial. J Endovasc Ther. 2004;11:613–620.CrossRefGoogle ScholarPubMed
11.Prinssen, M, Verhoeven, EL, Buth, J, et al. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. [see comment]. N Engl J Med. 2004;351:1607–1618.CrossRefGoogle ScholarPubMed
12.Ringleb, PA, Allenberg, J, Bruckmann, H, et al. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: A randomised non-inferiority trial. Lancet. 2006;368:1239–1247.Google ScholarPubMed
13.Vinck, I, Neyt, M, Thiry, N, et al. Een procedure voor de beoordeling van nieuwe medische hulpmiddelen. Health Technology Assessment (HTA). KCE reports 44A (D/2006/10.273/50). 2006.Google Scholar