独立行政法人 医薬品医療機器総合機構
メニュー
閉じる
閉じる
閉じる

添付文書、患者向医薬品ガイド、
承認情報等の情報は、
製品毎の検索ボタンをクリックしてください。

国際関係業務

Japan-US Synergies in Global Medical Device Innovation : Harmonization by Doing (HBD) at TCT

Print this session
E-mail this session to a colleague
Wednesday, October 24
8:00 AM - 12:30 PM
Room: C219

Session I. Keynote: The Japan-US Medical Device Landscape 2012

8:00 AM - 9:00 AM

Moderators: Mitchell W. Krucoff, Shigeru Saito

8:00 AM

“Japan First:” Speeding Device Introduction in Japan

Akihiro Koide

8:20 AM

Pragmatic Pre- and Post-Market Global Harmonization: Lessons from Japan and the United States

Kenneth J. Cavanaugh Jr

8:40 AM

Japan-US Synergies in the Global Marketplace: An Industry View

Neal Fearnot

Session II. Critical Limb Ischemia (CLI) in Japan and the United States

9:00 AM - 10:00 AM

Moderators: Neal Fearnot, Kazuo Kawahara
Discussants: Kenneth J. Cavanaugh Jr, Akihiro Koide, Mitchell W. Krucoff, Robert Thatcher, Christopher J. White, Hiroyoshi Yokoi

9:00 AM

CLI and Device Intervention in Japan

Hiroyoshi Yokoi

9:10 AM

CLI Definitions: Can We Speak the Same Language? Update on the Peripheral Academic Research Consortium(PARC)

Christopher J. White

9:20 AM

CLI and Device Intervention Across the Pacific: An FDA View

Kenneth J. Cavanaugh Jr

9:30 AM

Discussion

Break

10:00 AM - 10:30 AM

Session III. Percutaneous Valves in Japan and the United States

10:30 AM - 11:30 AM

Moderators: Masayuki Kawahara, John Laschinger
Discussants: Jodi Akin, Koji Ikeda, Fumiaki Ikeno, Michael J. Mack, David Reuter, Stanton J. Rowe, Huay Cheem Tan, Kim Trautman

10:30 AM

TAVR in Japan and the United States

Jodi Akin

10:40 AM

Percutaneous Mitral Valve: Where It Fits in Japan-US Today

David Reuter

10:50 AM

Pre- and Post-market Application of International Registries: The TVT Registry Example

Michael J. Mack

11:00 AM

Discussion

Session IV. Japan-US Synergies in Coronary Intervention

11:30 AM - 12:30 PM

Moderators: Kazuhiro Sase, Gary Thompson
Discussants: Andrew Farb, Akihiro Koide, Mitchell W. Krucoff, Stephen Rowland, Shigeru Saito, Kazuaki Sekiguchi, Huay Cheem Tan, Robert Thatcher, Takahiro Uchida

11:30 AM

Bioabsorbable Stent Components and Stents

Shigeru Saito

11:40 AM

Intervention in Calcific Coronary Arteries: An FDA View

Andrew Farb

11:50 AM

 

Biological Enhancement for Endothelial Capture

Mitchell W. Krucoff

12:00 PM

Discussion

Adjourn

12:30 PM - 12:30 PM