Japanese guidance for ventricular assist devices/total artificial hearts

Artificial Organs

Volumn 34, Issue 9, 2010, Pages 699-702

  Yamane, Takashi ^a,b   Kyo, Shunei ^c   Matsuda, Hikaru ^d   Abe, Yusuke ^e   Imachi, Kou ^e   Masuzawa, Toru ^f   Nakatani, Takeshi ^g   Sase, Kazuhiro ^h   Tabayashi, Koichi ⁱ   Takatani, Setsuo ^j   Tatsumi, Eisuke ^g   Umezu, Mitsuo ^k   Tsuchiya, Toshie ^l  

^a NATIONAL INSTITUTE OF ADVANCED INDUSTRIAL SCIENCE AND TECHNOLOGY AIST   (Japan)

^b PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^c UNIVERSITY OF TOKYO HOSPITAL   (Japan)

^d HYOGO COLLEGE OF MEDICINE   (Japan)

^e UNIVERSITY OF TOKYO   (Japan)

^f IBARAKI UNIVERSITY   (Japan)

^g NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^h JUNTENDO UNIVERSITY   (Japan)

ⁱ TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^j TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^k WASEDA UNIVERSITY   (Japan)

^l NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

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Author keywords

Evaluation criteria; Guidance; Total artificial heart; Ventricular assist device

Indexed keywords

LEFT VENTRICULAR ASSIST DEVICES;

EMERGING TECHNOLOGIES; EVALUATION CRITERIA; GUIDANCE; HOSPITAL PROJECTS; MEDICAL DEVICES; RESEARCH AND DEVELOPMENT; REVIEW PROCESS; TOTAL ARTIFICIAL HEARTS; VENTRICULAR ASSIST DEVICE; WORKING GROUPS;

ARTIFICIAL HEART;

ARTIFICIAL HEART; CLINICAL EVALUATION; HEART ASSIST DEVICE; HUMAN; JAPANESE; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHORT SURVEY; TECHNOLOGY;

EID: 77957266099     PISSN: 0160564X     EISSN: 15251594     Source Type: Journal    
DOI: 10.1111/j.1525-1594.2010.01091.x     Document Type: Short Survey

References (10)

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2. NIH. Phased readiness testing of implantable total artificial hearts. Request for proposal, NHLBI-HV-92-28 1992.
3. ASAIO-STS. Long-term mechanical circulatory support system reliability recommendation. Ann Thorac Surg 1998 66 : 1852 9.
4. AAMI. Ventricular assist and heart replacement systems. TIR26:2000.
5. JSAO. Clinical trial guidance for medical devices for serious heart diseases. 2003.
6. National Clinical Trial Initiative Subcommittee. Long-term mechanical circulatory support system reliability recommendation by the National Clinical Trial Initiative Subcommittee. ASAIO J 2009 55 : 534 42.
7. ISO. Implants for surgery - Active implantable medical devices, Part 5: particular requirements for circulatory support devices. ISO 14708-5 2010.
8. METI. R&D Guidelines for active implants 2007: innovative artificial heart systems. May 2007. Available at: http://www.meti.go.jp/policy/mono-info- service/service/iryou-fukushi/index.html. Accessed August 1, 2010.
9. MHLW. Notification by Director, OMDE, Yakushokuki-hatsu No. 0404002: evaluation criteria for emerging technology: clinical evaluation criteria for next-generation artificial hearts. April 4, 2008. Available at: http://dmd.nihs.go.jp/jisedai/heart/heart-public.pdf. Accessed August 1, 2010.
10. Tatsumi E, Nakatani T, Imachi K, et al. Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: a survey by the working group on establishment of assessment guidelines for next-generation artificial heart systems. J Artif Organs 2007 10 : 187 94. (Pubitemid 350243846)