On-X Life Technologies, Inc. (On-X LTI) was formerly
Medical Carbon Research Institute (MCRI).

Clinical Issues and Updates

Case Studies

Exceptional Quality of Life After On-X Valve Implant (pdf)
(Case Study 1)

The On-X Prosthetic Heart Valve gives a triathlete his running legs and heart.
Ten months after surgery, Lt. Silk competed in his first triathalon - an 800 meter swim, 20 mile bike race and 5 kilometer run.
Iron running with a pure carbon On-X mitral valve.

Clinical Updates

An Update of Clinical Update 24 (pdf)

The On-X Prosthetic Heart Valve -
Why Choose any other Mechanical Valve? (pdf)
(Clinical Update 23)

The potential exists for a reduced level of anticoagulant medication with the On-X valve depending on the outcome of the FDA approved PROACT study.
The study results could mean a better quality of life for patients due to lowered anticoagulation medication...
The first implant occurred on June 7, 2006,...enrollment of 1200 patients is expected...

Treatment for Osteoporosis May Affect Implanted Tissue Valves (pdf)

Is there a relationship between the consumption of daily calcium supplements and early leaflet calcification of implanted tissue valves in adults?
10 million Americans over the age of 50 have osteoporosis.
Another 34 million are at risk for developing osteoporosis.
...“ingestion of calcium phosphate...may increase the risk of calcium deposition in...the leaflets of implanted biological or bioprosthetic heart valves.”

Life Expectancy at 65 is Approaching 20 Years! (pdf)

The age group 85 and older is now the fastest growing segment of the U.S. population.
Freedom from explant [of tissue valves] for patients under 50 years old at 15 years is approximately 40%.
Reoperative mortality in older patients has been reported at 11.5% for patients 60-70 years and 32% for patients over 80 years.

Echocardiography Confirms Less Turbulence with the On-X Prosthetic Heart Valve (pdf)

Transesophageal echocardiography demonstrates dramatic differences between the On-X valve...and that of other mechanical valves.
...reduction of morbid event rates...can be explained in part by the lack of turbulence demonstrated by echocardiography.
Advanced design is reflected by the unique echocardiographic signature.

Non-compliant South African Patients Benefit from the On-X Prosthetic Heart Valve's Low Morbid Event Rates (pdf)

Results published...of this five-year observational study document fewer morbid events, especially thrombosis, despite less than 60% compliance with anticoagulation protocols!
Valve patients in the South African population have demonstrated high rates of thrombosis with other valve designs.
Only one valve [On-X] thrombosed during the five-year implant span...

Increased Survival with the On-X Prosthetic Heart Valve (pdf)

At five years, the On-X valve offers increased survival over both tissue and mechanical valves.
Based upon data..., the survival of On-X valve patients is greater that that for tissue valve patients in both aortic and mitral positions at five years.
Maximize your patients' chances for a longer, event-free life with the On-X valve.

Optimal Geometric Orifice Size in On-X Valves (pdf)

Advanced design characteristics of the On-X Prosthetic Heart Valve provide maximum efficiency in more annulus sizes.
Advanced features of the On-X valve allow for more flow size-for-size compared to that of other valves.
No benefits for increasing GOA above optimal in large mitral sizes.

Patient Friendly Mitral Valve (pdf)

Advanced design features of the On-X valve protect patients from stuck leaflets, pannus overgrowth and loud noise.
No reported postoperative impingement or pannus overgrowth of the On-X mitral valve in 9 years [now 11 years].
Patients, surgeons and cadiologists have reported that the On-X valve can be difficult to hear even in a quiet room.

A Mechanical Option To Tissue Valve Replacement? (pdf)

Substantial reduction of blood destruction and morbid events could lead to lowered INR for recipients of the On-X Prosthetic Heart Valve.

A need for complete understanding of alternatives
Tissue prosthetic implant must be re-examined
Summary of morbid event rates for bioprostheses and mechanical valves
Structural deterioration of tissue valves is hazardous to patients
Reoperative mortality increases with patient age
Comparison of On-X valve and tissue valve morbid event rates
The On-X valve reduces morbid event rates and reoperation
Stentless valves are not a hemodynamic advantage to the On-X valve
% of patients mismatched for different prosthetic valves

On-X Valve Design is Less Hemolytic (pdf)

A break-through in materials technology and heart valve design reduces blood cell rupture and decreases morbid event levels.

Comparison of LDH Values in Heart Valves (percent of LDH upper normal)
On-X valve design significantly reduces turbulence and blood damage
Traumatic hemolysis arises from outdated valve design
Cavitation and microbubble formation from outdated valve design is associated with hemolysis
Increased cavitation resistance makes the On-X valve design more tolerant of INR fluctuation
Comparison of cavitation resistance of heart valves

The Non-Compliant Patient (pdf)

Published data reveal a mechanical valve tolerant of low or fluctuating INR values.

What is the ideal range of INR for patients with mechanical valves?
Bleeding risk is consistent for every patient taking anticoagulation treatment.
Incidence of thromboembolic and bleeding complications with different intensities of oral anticoagulation.
Thromboembolic risk is dependent on valve design and materials.
Why the On-X valve's thrombotic risk versus anticoagulation intensity curve is better.
The On-X Prosthetic Heart Valve is the only mechanical valve that represents an advance in hemodynamic design made possible by advances in carbon technology.

Natural Valve Design for Patients with Small Aortic Roots (pdf)

The On-X Prosthetic Heart Valve offers patients of all ages greater exercise tolerance and reduced complications.

Stenotic blood flow through prostheses in the small aortic root
A meaningful history of valve design
Success with natural flow
Lowest morbid event rates
Tissue prosthesis inadequacy
Beyond hemodynamics
Life without a second surgery

Pure On-X Carbon Provides Improved Hemocompatability (pdf)

Pure On-X Carbon helps lower complication rates for On-X valve patients.

On-X carbon's pristine surfaces and hemocompatability of pure carbon
Pyrolytic carbon coating reactor
Surface area variations compared to target
Lack of control resulted in undesirable aspects of silicon alloyed pyrolytic carbon
Technological breakthrough provides precise control
On-X carbon's strength made possible the On-X valve design's:
- near-natural flow with minimal turbulence
- high effective orifice areas
- reduced morbidity

On-X Valve Patients Experience Improved Outcomes Despite Fluctuations in INR Values (pdf)

The On-X valve is already providing significant benefits to patients. In the future, On-X patients may have more anticoagulation freedom than has ever existed with a mechanical valve.

South African Study Follow-up
Anticoagulation Compliance
On-X Major / Permanent Valve-Related Morbid Events
Comparison of Mitral Thrombosis Rates
South African patients with INR values below 1.5 experience:
- 0 hemorrhage
- 0 thrombosis
- 0.4% per patient year thromboembolism

Reduced Postoperative On-X Valve Complications Result in Lower Treatment Costs (pdf)

The On-X valve helps reduce the cost of postoperative patient care.

Better Patient Care / Lower Patient Cost
The Cost of Complications
Average Costs of Managing Valve-Related Complications and Sequelae
Annual Cost Savings with the On-X Heart Valve

On-X Prosthetic Heart Valve (pdf)

The On-X valve: a barrier to pannus encroachment and leaflet interference.

Pannus Ingrowth - a serious complication of valve implantation
Protection from Pannus Ingrowth by valve design
Full Annular Support with Supra-annular Cuff Placement
Protection of Leaflets from Retained Mitral Apparatus

On-X Valve - A Pivotal Performance (pdf)

The On-X valve pivot design minimizes blood damage, resulting in reduced thrombotic complications for patients.

A More Natural Design
How it Works
Optimal Pivot Purging
Contoured Pathways
Clinical Relevance

On-X Prosthetic Heart Valve - Superior Hemodynamics (pdf)

The Thrill is Gone! With On-x aortic valves, surgeons report an absence of a “thrill” within the aorta of implanted patients.

What Thrill?
The On-X valve is “Designed for Life”
The On-X valve has the lowest gradient in size 19 of any valve prosthesis!
The On-X valve provides less mismatch than any other mechanical valve
Hemodynamic Performance
The On-X valve provides a solution to the small aortic root challenge
The NEW THRILL is NO THRILL!

On-X Valves - The Best of Both Worlds (pdf)

On-X valves present a possible solution to the valve choice dilemma.

The current Valve Choice Dilemma
Bleeding Rates
Actuarial Freedom from Reoperation
Reoperative Mortality
Advances in Valve Performance