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News Conference News TCT 2016

ILLUMENATE: Low-Dose DCB Bests Angioplasty Alone in Complex Patients With SFA/Popliteal Lesions

L.A. McKeown

November 07, 2016

News Conference News

Watchman, Amulet LAA Closure Devices Carry Low Complication Rates

Todd Neale

November 04, 2016

Presentation TCT 2016

WATCHMAN US POST-APPROVAL STUDY: Multicenter, Prospective, Registry Results With a Left Atrial Appendage Closure Device for Stroke Prevention in Patients With Atrial Fibrillation

Presenter: Martin B. Leon, Louis A. Cannon, David R. Holmes Jr.

November 02, 2016

Presentation TCT 2016

Reimbursement Challenges For LAAC: Balancing The Clinical Need Vs. Robust Data Vs. Societal Economic Considerations

Presenter: Aaron V. Kaplan, Rachel Neubrander, Tamara Syrek Jensen

November 01, 2016

Presentation TCT 2016

Pivotal Trial Design Considerations: Noninferiority vs Superiority, Device, Control Arm Anticoagulation Durations, NOAC Considerations and More Industry and Clinician Perspectives

Presenter: Aaron V. Kaplan, Rachel Neubrander, Brian K. Whisenant

November 01, 2016

Presentation TCT 2016

Trial Designs For LAA Closure: Potential Regulatory Pathways and Unanswered Questions What FDA Would Like to See

Presenter: Aaron V. Kaplan, Rachel Neubrander, Katherine Wallon

November 01, 2016

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

Benefit of Supersaturated Oxygen for Large Anterior STEMI: From ICI-HOT to Approval?

Presenter: Cindy L. Grines, Holger Thiele, Gregg W. Stone

October 31, 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 Conference News TCT 2016

LEADERS FREE: Polymer-Free DES Maintains Superior Safety, Efficacy Over BMS at 2 Years

Yael L. Maxwell

October 30, 2016

News Conference News TCT 2016

Impella CP Fails to Show Benefit in Exploratory Study of Patients With Severe Cardiogenic Shock

Todd Neale

October 29, 2016

News Daily News

FDA Approves Amplatzer PFO Occluder for Prevention of Recurrent Stroke

Yael L. Maxwell

October 28, 2016

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ILLUMENATE: Low-Dose DCB Bests Angioplasty Alone in Complex Patients With SFA/Popliteal Lesions

Watchman, Amulet LAA Closure Devices Carry Low Complication Rates

WATCHMAN US POST-APPROVAL STUDY: Multicenter, Prospective, Registry Results With a Left Atrial Appendage Closure Device for Stroke Prevention in Patients With Atrial Fibrillation

Reimbursement Challenges For LAAC: Balancing The Clinical Need Vs. Robust Data Vs. Societal Economic Considerations

Pivotal Trial Design Considerations: Noninferiority vs Superiority, Device, Control Arm Anticoagulation Durations, NOAC Considerations and More Industry and Clinician Perspectives

Trial Designs For LAA Closure: Potential Regulatory Pathways and Unanswered Questions What FDA Would Like to See

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

Benefit of Supersaturated Oxygen for Large Anterior STEMI: From ICI-HOT to Approval?

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

LEADERS FREE: Polymer-Free DES Maintains Superior Safety, Efficacy Over BMS at 2 Years

Impella CP Fails to Show Benefit in Exploratory Study of Patients With Severe Cardiogenic Shock

FDA Approves Amplatzer PFO Occluder for Prevention of Recurrent Stroke

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