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Biodegradable Drug-Eluitng Stent (Powerstent®Absorb) for coronary arterial disease----development and commercialization plan.

Record Type:	Electronic resources : Monograph/item
Title/Author:	Biodegradable Drug-Eluitng Stent (Powerstent®Absorb) for coronary arterial disease----development and commercialization plan./
Author:	Wu, Tim Tiangen.
Description:	1 online resource (115 pages)
Notes:	Source: Dissertations Abstracts International, Volume: 75-12, Section: B.
Contained By:	Dissertations Abstracts International75-12B.
Subject:	Biomedical engineering. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3580184click for full text (PQDT)
ISBN:	9781303884757

Biodegradable Drug-Eluitng Stent (Powerstent®Absorb) for coronary arterial disease----development and commercialization plan.
Wu, Tim Tiangen.

Biodegradable Drug-Eluitng Stent (Powerstent®Absorb) for coronary arterial disease----development and commercialization plan. - 1 online resource (115 pages)

Source: Dissertations Abstracts International, Volume: 75-12, Section: B.

Thesis (Ph.D.)--University of Massachusetts Lowell, 2014.

Includes bibliographical references

The overall goal of this study was to design and develop a novel Biodegradable, Drug-Eluting Stent (BDES, PowerStent® Absorb) for coronary arterial disease (CAD) applications. CAD is a major cause of death in the United States, and implantation of DES following angioplasty of an occluded artery is the current standard of care. Despite the prevalent use of DES in current clinical interventional practice, there are significant drawbacks, including the need for long-term anti-platelet therapy to prevent late-stage thrombosis, as well as the metal artifact left in the vessel which precludes the vessel from returning to its natural state and prevents true endothelial repair and arterial remodeling. Therefore, clinical consensus is building that fully BDES represent the next generation in DES. However, all current investigational BDES technology cause an inflammatory response at the site of deployment, within the vessel wall, and lack of sufficient radial strength to prevent a stented artery from recoiling and collapsing after plaque is removed following a percutaneous transcutaneous balloon angioplasty (PTCA) procedure. Our solution to those issues is the PowerStent® Absorb BDES as presented herein. It is a standalone product that embodies 3 technology breakthroughs: (1) A nanoparticle reinforced, inflammatory-free biodegradable polymer (BioDe®); (2) A long-duration, sustained-release anti-restenosis drug (paclitaxel) formulation; and (3) A feature-designed, radially-reinforced drug delivery scaffold. Several iterations of the original design were fabricated, and hundreds were manufactured and performance tested in-vitro and in-vivo. These data are intended to be included in a pre-clinical IDE application in support of a First-In-Man (FIM) clinical trial of the PowerStent®Absorb stent in 60 patients with CAD. It is the intent to commercialize this product for CAD and to expand the application of this BDES technology into other important vascular indications.

Electronic reproduction.
Ann Arbor, Mich. :
ProQuest,
2023

Mode of access: World Wide Web

ISBN: 9781303884757Subjects--Topical Terms:

535387
Biomedical engineering.
Subjects--Index Terms:

Biodegradable PolymerIndex Terms--Genre/Form:

542853
Electronic books.

Biodegradable Drug-Eluitng Stent (Powerstent®Absorb) for coronary arterial disease----development and commercialization plan.
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520 $a The overall goal of this study was to design and develop a novel Biodegradable, Drug-Eluting Stent (BDES, PowerStent® Absorb) for coronary arterial disease (CAD) applications. CAD is a major cause of death in the United States, and implantation of DES following angioplasty of an occluded artery is the current standard of care. Despite the prevalent use of DES in current clinical interventional practice, there are significant drawbacks, including the need for long-term anti-platelet therapy to prevent late-stage thrombosis, as well as the metal artifact left in the vessel which precludes the vessel from returning to its natural state and prevents true endothelial repair and arterial remodeling. Therefore, clinical consensus is building that fully BDES represent the next generation in DES. However, all current investigational BDES technology cause an inflammatory response at the site of deployment, within the vessel wall, and lack of sufficient radial strength to prevent a stented artery from recoiling and collapsing after plaque is removed following a percutaneous transcutaneous balloon angioplasty (PTCA) procedure. Our solution to those issues is the PowerStent® Absorb BDES as presented herein. It is a standalone product that embodies 3 technology breakthroughs: (1) A nanoparticle reinforced, inflammatory-free biodegradable polymer (BioDe®); (2) A long-duration, sustained-release anti-restenosis drug (paclitaxel) formulation; and (3) A feature-designed, radially-reinforced drug delivery scaffold. Several iterations of the original design were fabricated, and hundreds were manufactured and performance tested in-vitro and in-vivo. These data are intended to be included in a pre-clinical IDE application in support of a First-In-Man (FIM) clinical trial of the PowerStent®Absorb stent in 60 patients with CAD. It is the intent to commercialize this product for CAD and to expand the application of this BDES technology into other important vascular indications.
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