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Presentation TCT 2016

Possible Approval Pathways for New Mitral and Tricuspid Valve Therapies

Presenter: Matthew G. Hillebrenner, Michael J. Mack, John C Laschinger

November 01, 2016

Presentation TCT 2016

FDA Perspectives on TAVR Label Expansion (E.G. Lower Risk Patients, Bicuspid Aortic Stenosis and Aortic Insufficiency), and New and Iterative Device Approval Pathways

Presenter: Nicole Ibrahim, Martin B. Leon, Jaime Raben

November 01, 2016

Presentation TCT 2016

Industry Perspectives: Balancing Innovation and Robust Clinical Evidence Generation With Declining DES Use and Reimbursement

Presenter: Michael C. John, Gregg W. Stone, Jason R. Weidman

November 01, 2016

Presentation TCT 2016

Bioresorbable Scaffolds - Lessons Learned From the ABSORB Odyssey: Industry Perspectives

Presenter: Michael C. John, Gregg W. Stone, Chuck Simonton

November 01, 2016

Presentation TCT 2016

FDA Perspectives on Short DAPT IDE Trials

Presenter: Michael C. John, Gregg W. Stone, Andrew Farb

November 01, 2016

Presentation TCT 2016

FDA Regulatory Considerations for Novel and Not-So-Novel New Metallic DES and Bioresorbable Scaffolds

Presenter: Michael C. John, Gregg W. Stone, P.F. Adrian Magee

November 01, 2016

News Conference News TCT 2016

Final RESPECT Data Support PFO Closure for Cryptogenic Stroke Prevention

Yael L. Maxwell

November 01, 2016

Presentation TCT 2016

Strengths and Limitations of Post-Approval Registries as Vehicles to Track Safety and Inform Device Label Expansion

Presenter: Owen Faris, Mitchell W. Krucoff, David R. Holmes Jr.

October 31, 2016

Presentation TCT 2016

Device Performance in Pre-Approval Studies vs Unrestricted Real-World Use: Lessons Learned and Future Opportunities

Presenter: Owen Faris, Mitchell W. Krucoff

October 31, 2016

Presentation TCT 2016

Key Note Lecture II. Regulatory Reform of Medical Device Approvals by the European Commission Motivating Factors, Anticipated Changes, and Timelines

Presenter: Matthew G. Hillebrenner, Gregg W. Stone, Alan G. Fraser

October 31, 2016

News Industry News

Study Finds Ridaforolimus-Eluting Stent is Non-Inferior to Zotarolimus-Eluting Stent Based On One-Year Clinical Outcomes

October 30, 2016

News Daily News

FDA Approves Amplatzer PFO Occluder for Prevention of Recurrent Stroke

Yael L. Maxwell

October 28, 2016

News Daily News

La FDA Aprueba el Oclusor del FOP Amplatzer para la Prevención de ACV Recurrentes

Yael L. Maxwell

October 28, 2016

News Daily News

FDA 批准 PFO 封堵器用于预防中风复发

Yael L. Maxwell

October 28, 2016

News Industry News

Corindus Vascular Robotics Receives FDA Clearance for Next Generation Robotic System

October 27, 2016

News Daily News

FDA Approves 34-mm TAVR Valve for Patients With Larger Anatomy

L.A. McKeown

October 27, 2016

News Industry News

SentreHEART Announces Closing of $35M Funding Round for aMAZE Trial

October 03, 2016

News Daily News

某些患者 TAVR 后认知改善，但也有些下降，导致很难有统一指南

Shelley Wood

September 29, 2016

News Daily News

Post-TAVR Cognition Improves in Some Patients and Declines in Others, With Few Signposts to Guide the Way

Shelley Wood

September 29, 2016

News Daily News

La Cognición Post-TAVR Mejora en Algunos Pacientes y Desciende en Otros y son Pocas las Señales Orientativas

Shelley Wood

September 29, 2016

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Possible Approval Pathways for New Mitral and Tricuspid Valve Therapies

FDA Perspectives on TAVR Label Expansion (E.G. Lower Risk Patients, Bicuspid Aortic Stenosis and Aortic Insufficiency), and New and Iterative Device Approval Pathways

Industry Perspectives: Balancing Innovation and Robust Clinical Evidence Generation With Declining DES Use and Reimbursement

Bioresorbable Scaffolds - Lessons Learned From the ABSORB Odyssey: Industry Perspectives

FDA Perspectives on Short DAPT IDE Trials

FDA Regulatory Considerations for Novel and Not-So-Novel New Metallic DES and Bioresorbable Scaffolds

Final RESPECT Data Support PFO Closure for Cryptogenic Stroke Prevention

Strengths and Limitations of Post-Approval Registries as Vehicles to Track Safety and Inform Device Label Expansion

Device Performance in Pre-Approval Studies vs Unrestricted Real-World Use: Lessons Learned and Future Opportunities

Key Note Lecture II. Regulatory Reform of Medical Device Approvals by the European Commission Motivating Factors, Anticipated Changes, and Timelines

Study Finds Ridaforolimus-Eluting Stent is Non-Inferior to Zotarolimus-Eluting Stent Based On One-Year Clinical Outcomes

FDA Approves Amplatzer PFO Occluder for Prevention of Recurrent Stroke

La FDA Aprueba el Oclusor del FOP Amplatzer para la Prevención de ACV Recurrentes

FDA 批准 PFO 封堵器用于预防中风复发

Corindus Vascular Robotics Receives FDA Clearance for Next Generation Robotic System

FDA Approves 34-mm TAVR Valve for Patients With Larger Anatomy

SentreHEART Announces Closing of $35M Funding Round for aMAZE Trial

某些患者 TAVR 后认知改善，但也有些下降，导致很难有统一指南

Post-TAVR Cognition Improves in Some Patients and Declines in Others, With Few Signposts to Guide the Way

La Cognición Post-TAVR Mejora en Algunos Pacientes y Desciende en Otros y son Pocas las Señales Orientativas

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