Heart of Carbon: The Story Behind the Pursuit of the Perfect Mechanical Heart Valve

Foreword by John D. Puskas, MD
Foreword by Mervyn Williams
Acknowledgments
Contents
Abbreviations
Contents
Contents
Chapter 1: Overview
Chapter 2: Nuclear Foundations
	Grappling with a Serious Problem
	A Brush with the Not Discovered Here Mentality
	Another Rung on the Academic Ladder
	More Experience with Reactors
	The Final Rung of the Academic Ladder
	Diving Back into Industry
	References
Chapter 3: Origin and Characterization of Medical Carbons
	Black Box Analysis
	New Directions Based on New Evidence
	References
Chapter 4: Gott’s Early Experience: A Lesson in Serendipity
	The Artificial Heart Program
	The Gordon Conference
	General Atomic Enters the World of the Artificial Heart Program
	Following the Evidence Where It Leads
	Where the Studies Led
	References
Chapter 5: First Carbon Heart Valve Replacement
	Navigating Unforeseen Complications
	Manufacturing the First Hollow Balls
	The Valves that Took a Detour
	DeBakey-Surgitool Valves In Vivo
	References
Chapter 6: First All-Carbon Mitral Valve Replacement
	The Beall Valves Advance the State of the Art
	A Major Wake-Up Call
	One Patient’s Three-Decade Track Record
	At the Dawn of the Industry
	References
Chapter 7: Monoleaflet Tilting Disc Valves
	An Unforeseen New Problem Arises
	Business Complexities Take Center Stage
	Large Black Smudge on Laboratory Exterior Wall
	An Invited Visit to the Italian Company Facility
	Marshall Kriesel and Medical Incorporated
	Shiley Laboratories Develops Its Valve Designs
	Medical Inc. Designs an Improved Valve
	Medical Incorporated’s Omnicarbon Valve
	Shiley’s Struggles with Strut Failure
	The Key to the Future
	References
Chapter 8: First Bileaflet Valve: St. Jude Medical Inc. Start-Up
	Accommodating Demands for an Inspection
	Reference
Chapter 9: General Atomic Inc. Medical Products Division Sold to Intermedics Inc.
Chapter 10: CarboMedics Inc. Gets Acquainted with Intermedics Inc.
Chapter 11: CarboMedics Inc. Moves to Austin Texas
	The New Facility in Austin
	New Facility, New Problems
	Reference
Chapter 12: The Hemex Inc. Venture
	The Dawn of Hemex, Inc.
	Reaching beyond Carbon Heart Valve Replacement
	References
Chapter 13: The St. Jude Medical Inc. Litigation
	Dirty Tricks That Backfired
	Reference
Chapter 14: Broadening the Horizon
	References
Chapter 15: Two Valves for China
	“Call Me Ned”
	Rollie Siegel Joins CarboMedics, Inc.
	First Steps in China
	Bringing Carbon to Beijing
	First Human Implant of the CarboMedics, Inc. Replacement Valve
	References
Chapter 16: Negotiating Chinese Joint Venture
Chapter 17: European Company Buys Intermedics Inc.
	References
Chapter 18: Medtronic Inc. Project
	A Key Technical Breakthrough
	The Accuntius/Wilde Patent Makes a New Pure Carbon Valve
	References
Chapter 19: Medical Carbon Research Institute LLC/On-X Life Technologies Inc.
	Visit to a Vineyard
Chapter 20: Valve Design
	A Flare for Valve Design
	High-Impact Versus Low-Impact Valve Closure
	References
Chapter 21: Clinical Trials
	A Pause to Reflect Important Events
	References
Chapter 22: Design Validation
	Leonard da Vinci Lays Down the Law
	“The Thrill Is Gone!”
	References
Chapter 23: Studies Concurrent with FDA Trials
	Mervyn Williams and the South African Study
	Belgium Reports In
	Putting the Pieces All Together
	Promoting the On-X Valve
	References
Chapter 24: Understanding Cardiac Blood Flow
	Gerald Buckberg and the Advance of Heart Science
	References
Chapter 25: Investigating the Viability of Bioprostheses
	Reference
Chapter 26: On-X Valve Implantability
	What’s in a Shape?
	References
Chapter 27: Selling the On-X Valve
	Encountering Unexpected Resistance
Chapter 28: The Leonardo da Vinci Video
	Marketing Philosophies in Conflict
	References
Chapter 29: Gerald Buckberg Joins the Video Project
	Misconceptions That Could Have Been Prevented
	Big News from the FDA
	References
Chapter 30: A Surprise from Northwestern University
	The Video Continues to Evolve
	Too Little Too Late?
	The Video and the In-House Critics
	References
Chapter 31: CryoLife Inc. Buys On-X Life Technologies Inc.
Chapter 32: Mervyn Williams’s South African Trial of the On-X Valve
	Introduction
	Surgical Procedure
	Results
	Discussion
	Conclusion
	References
Chapter 33: Summary and Reflections
	Appendix
		Summary and Conclusions
			Reliability of Pyrolytic Carbon for Heart Valve Application
			Fatigue Crack Growth Threshold
			Does Pyrolytic Carbon Fatigue At All?
			Probability of Failure and Weibull Statistics
			Micro Cracks
			Microstructure of Pyrolytic Carbon
			Conclusions
References
Index