Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan von Shiba, Takeshi, Aizawa, Koichi, Ho, Mami, Ishii, Kensuke

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data von Inuzuka, Ryo, Tachimori, Hisateru, Kim, Sung-Hae, Matsui, Hikoro, Kobayashi, Tohru, Kato, Atsuko, Fujii, Takanari, Ho, Mami, Morikawa, Hanako, Takahashi, Sara, Shirato, Haruki, Haishima, Yuji, Okamoto, Yoshihiro, Sakoda, Hideyuki, Tomita, Hideshi

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System von Mitsutake, Yoshiaki, Konishi, Akihide, Handa, Nobuhiro, Ho, Mami, Shirato, Haruki, Ito, Takuya, Koike, Kazuhisa, Mochizuki, Shuichi, Ishii, Kensuke

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First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　― Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent von Konishi, Akihide, Ho, Mami, Shirai, Yuko, Shirato, Haruki

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Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States von Takahashi, Sara, Iwasaki, Kiyotaka, Shirato, Haruki, Ho, Mami, Umezu, Mitsuo

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Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration P... von Yokoi, Hiroyoshi, Ho, Mami, Iwamoto, Shin, (on behalf of the authors)

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Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI)　― A Joint USA-Japanese Perspective von Yokoi, Hiroyoshi, Ho, Mami, Iwamoto, Shin, Suzuki, Yuka, Ansel, Gary M., Azuma, Nobuyoshi, Handa, Nobuhiro, Iida, Osamu, Ikeda, Koji, Ikeno, Fumiaki, Ohura, Norihiko, Rosenfield, Kenneth, Rundback, John, Terashi, Hiroto, Uchida, Takahiro, Yokoi, Yoshiaki, Nakamura, Masato, Jaff, Michael R.

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold von Konishi, Akihide, Ho, Mami, Mitsutake, Yoshiaki, Ouchi, Takashi, Nakamura, Masato, Shirato, Haruki

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Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children von Takahashi, Sara, Ibrahim, Nicole, Yasukochi, Satoshi, Ringel, Richard, Ing, Frank, Tomita, Hideshi, Sugiyama, Hisashi, Yamagishi, Masaaki, Forbes, Thomas J., Kim, Sung-Hae, Ho, Mami, Gillette, Nicole, Nakamura, Yasuko, Mineta, Koji, Fearnot, Neal, Dineen, Declan, Vang, Eric, Haskin, Russel, Becker, Lisa A. M., Sekiguchi, Kazuaki, Sakamoto, Kisaburo, Ruiz, Carlos E., on behalf of the Harmonization by Doing for Children Working Group

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Regulatory approval review of transcatheter mitral valve repair – Difference in the indication between the USA and Japan von Konishi, Akihide, Ho, Mami, Ouchi, Takashi, Mitsutake, Yoshiaki, Shirato, Haruki

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Patient and lesion characteristics in late/very late stent thrombosis with everolimus-eluting stents from real-world adverse event reporting von Konishi, Akihide, Mitsutake, Yoshiaki, Ho, Mami, Handa, Nobuhiro, Koike, Kazuhisa, Mochizuki, Shuichi, Ishii, Kensuke

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Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Ja... von Mitsutake, Yoshiaki, Konishi, Akihide, Shiba, Takeshi, Ito, Takuya, Ho, Mami, Shirato, Haruki

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Valve Academic Research Consortium Consensus Report von Ikeda, Koji, PhD, Ho, Mami, MD, PhD, Kawahara, Masayuki, MD

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Regulatory Review of Robotic-Assisted Percutaneous Coronary Intervention in Japan von Shiba, Takeshi, Aizawa, Koichi, Ho, Mami, Ishii, Kensuke

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Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease von Patel, Manesh R., MD, Conte, Michael S., MD, Cutlip, Donald E., MD, Dib, Nabil, MD, Geraghty, Patrick, MD, Gray, William, MD, Hiatt, William R., MD, Ho, Mami, MD, PhD, Ikeda, Koji, PhD, Ikeno, Fumiaki, MD, Jaff, Michael R., DO, Jones, W. Schuyler, MD, Kawahara, Masayuki, MD, Lookstein, Robert A., MD, Mehran, Roxana, MD, Misra, Sanjay, MD, Norgren, Lars, MD, Olin, Jeffrey W., MD, Povsic, Thomas J., MD, PhD, Rosenfield, Kenneth, MD, Rundback, John, MD, Shamoun, Fadi, MD, Tcheng, James, MD, Tsai, Thomas T., MD, Suzuki, Yuka, PhD, Vranckx, Pascal, MD, Wiechmann, Bret N., MD, White, Christopher J., MD, Yokoi, Hiroyoshi, MD, Krucoff, Mitchell W., MD

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Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC) von Patel, Manesh R, Conte, Michael S, Cutlip, Donald E, Dib, Nabil, Geraghty, Patrick, Gray, William, Hiatt, William R, Ho, Mami, Ikeda, Koji, Ikeno, Fumiaki, Jaff, Michael R, Jones, W Schuyler, Kawahara, Masayuki, Lookstein, Robert A, Mehran, Roxana, Misra, Sanjay, Norgren, Lars, Olin, Jeffrey W, Povsic, Thomas J, Rosenfield, Kenneth, Rundback, John, Shamoun, Fadi, Tcheng, James, Tsai, Thomas T, Suzuki, Yuka, Vranckx, Pascal, Wiechmann, Bret N, White, Christopher J, Yokoi, Hiroyoshi, Krucoff, Mitchell W

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Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, a Harmonization by Doing Proof-of-Concept: The Japanese and US Regulatory Perspective von Iwamoto, Shin, Ohashi, Moe, Shirato, Haruki, Ho, Mami, Malone, Misti, Cavanaugh, Kenneth

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Independent Factors for In-Hospital Death Following Drug-Eluting Stent Thrombosis From the Japanese Adverse Event Report System von Mitsutake, Yoshiaki, Konishi, Akihide, Handa, Nobuhiro, Ho, Mami, Shirato, Haruki, Ito, Takuya, Koike, Kazuhisa, Mochizuki, Shuichi, Ishii, Kensuke

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Recent Least Burdensome Approach for the Approval of Innovative Medical Devices in Japan -Regulatory Approval Review of an Everolimus-eluting Bioresorbable Scaffold von Konishi, Akihide, Ho, Mami, Mitsutake, Yoshiaki, Ouchi, Takashi, Nakamura, Masato, Shirato, Haruki

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Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data von Inuzuka, Ryo, Tachimori, Hisateru, Kim, Sung-Hae, Matsui, Hikoro, Kobayashi, Tohru, Kato, Atsuko, Fujii, Takanari, Ho, Mami, Morikawa, Hanako, Takahashi, Sara, Shirato, Haruki, Haishima, Yuji, Okamoto, Yoshihiro, Sakoda, Hideyuki, Tomita, Hideshi

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