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Presentation TCT 2013

Regulatory Approval Models for Iterative (Next Version) TAVR Devices: Do We Need RCTS or OPC-Controlled Registries?

Presenter: Jeffrey Popma

October 30, 2013

Presentation TCT 2013

Keynote Address: The Intersection of Innovation, Payment and Regulatory Approval in the Future of Interventional Cardiology

Presenter: Jack Lewin

October 30, 2013

Presentation TCT 2013

Experimental and Regulatory Strategy: The Need of a “Global Integrated” Approach

Presenter: Greg Kaluza

October 30, 2013

Presentation TCT 2013

Are Regulatory Approval Clinical Trials Too Complex and Too Costly for New Devices and New Indications? EXCEL and BVS Experience.

Presenter: Charles Simonton

October 30, 2013

News Conference News TCT 2013

Regulatory Hurdles Pose Challenges for Device Approvals in US, Europe

October 30, 2013

News Conference News TCT 2013

Need, Potential Exist for Global Integrated Regulatory Approach in Cardiology

October 30, 2013

News Conference News TCT 2013

CRF President Calls for Adaptability in the Face of Innovation, Health Care Reform

October 30, 2013

Presentation TCT 2013

Refining the Retrograde Technique: Technical and Regulatory Aspects

Presenter: Amit Patel

October 29, 2013

News Conference News TCT 2013

State of the Stent: PCI Future Intact Despite Costs, Sociopolitical Factors

October 29, 2013

News Industry News

St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study

October 29, 2013

News Industry News

Global Bifurcation Leader Tryton Medical Announces Events at TCT 2013

October 29, 2013

Presentation TCT 2013

What Are the Unmet Transradial Device Needs and How Should New Radial Devices Be Evaluated? Regulatory Perspectives

Presenter: Mitchell Krucoff

October 28, 2013

Presentation TCT 2013

The State-of the-Stent: US and Global Trends in Stent Use and Price, and Perspectives on Sociopolitical and Regulatory Forces

Presenter: Stephan Windecker

October 28, 2013

Presentation TCT 2013

The Case for Dedicated Bifurcation Stents; Device and Regulatory Landscape; and Anticipation of the Pivotal Tryton Results

Presenter: Martin Leon

October 28, 2013

Presentation TCT 2013

Keynote Lecture: Emerging Regulatory and Financial Changes: Impact on Global Medical Device Innovation

Presenter: Jack Lewin

October 28, 2013

News Conference News TCT 2013

Experts Discuss Efficacy, Safety of Watchman Device

October 28, 2013

News Conference News TCT 2013

Debate Continues on Use of Heart Teams for High-Risk Patients with Heart Valve Disease

October 28, 2013

Presentation TCT 2013

PFO Closure: Regulatory Reform, FDA Approval, and Rational Dispersion in the United States

Presenter: John Carroll

October 27, 2013

Presentation TCT 2013

FDA Perspectives: Clinical Trial Regulatory Pathway for Renal Denervation Devices

Presenter: Andrew Farb

October 27, 2013

News Industry News

Boston Scientific Reports Favorable Clinical Trial Results Assessing The OffRoad™ Re-Entry Catheter System

October 11, 2013

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Regulatory Approval Models for Iterative (Next Version) TAVR Devices: Do We Need RCTS or OPC-Controlled Registries?

Keynote Address: The Intersection of Innovation, Payment and Regulatory Approval in the Future of Interventional Cardiology

Experimental and Regulatory Strategy: The Need of a “Global Integrated” Approach

Are Regulatory Approval Clinical Trials Too Complex and Too Costly for New Devices and New Indications? EXCEL and BVS Experience.

Regulatory Hurdles Pose Challenges for Device Approvals in US, Europe

Need, Potential Exist for Global Integrated Regulatory Approach in Cardiology

CRF President Calls for Adaptability in the Face of Innovation, Health Care Reform

Refining the Retrograde Technique: Technical and Regulatory Aspects

State of the Stent: PCI Future Intact Despite Costs, Sociopolitical Factors

St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study

Global Bifurcation Leader Tryton Medical Announces Events at TCT 2013

What Are the Unmet Transradial Device Needs and How Should New Radial Devices Be Evaluated? Regulatory Perspectives

The State-of the-Stent: US and Global Trends in Stent Use and Price, and Perspectives on Sociopolitical and Regulatory Forces

The Case for Dedicated Bifurcation Stents; Device and Regulatory Landscape; and Anticipation of the Pivotal Tryton Results

Keynote Lecture: Emerging Regulatory and Financial Changes: Impact on Global Medical Device Innovation

Experts Discuss Efficacy, Safety of Watchman Device

Debate Continues on Use of Heart Teams for High-Risk Patients with Heart Valve Disease

PFO Closure: Regulatory Reform, FDA Approval, and Rational Dispersion in the United States

FDA Perspectives: Clinical Trial Regulatory Pathway for Renal Denervation Devices

Boston Scientific Reports Favorable Clinical Trial Results Assessing The OffRoad™ Re-Entry Catheter System

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