ATS Medical Demo Mitral Valve

Description
This is an ATS Medical Demo Mitral Valve, model 500DM31, size 31 mm. It is also known as the ATS Open Pivot Bi-leaflet Heart Valve. It has a low profile bi-leaflet valve with a polyester sewing ring. Etched into both leaflets is "DEMO/031". The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. The leaflets are made of solid pyrolytic carbon with a thin titanium band. More than 140,000 valves have been implanted worldwide. The blue, plastic rod contained within is called a "leaflet actuator" which positions the valve for implantation. The label on the container reads "Not For Human Use" and “To be used by "01JAN1999." Also on the container are images of Da Vinci's Vitruvian Man.
The ATS Open Pivot valve received the Commission European mark of approval in 1995. This mark is an "international symbol of quality assurance and compliance with applicable European Medical Device Directives" The valve had fewer complications in comparison to the Carbomedics valve and was ranked number one (sample of 116 patients) for valve noise, or lack thereof. 67.3% categorized it as "not noticeable". In another pamphlet, this became a selling point, "The ATS Medical Open Pivot valve is exceptionally quiet...its sound level out of the hearing range of most patients." It was ranked as being quieter than the St. Jude Medical valve.
From December 1992 to January 1994, 39 aortic valve replacements were performed using the ATS valve. Preliminary results were promising--low noise and low thromogenicity.
ATS Medical was founded in 1992 by Manuel “Manny” Villafaña, and was later acquired by Medtronic Inc. in April 2010.
Location
Currently not on view
Object Name
cardiology
artificial heart valve
date made
1996-01
maker
ATS Medical
Physical Description
plastic (valve holder/rotator material)
cardboard, plastic (box container material)
polyester fabric (valve material)
pyrolytic carbon (valve material)
Measurements
valve: 1.4 cm x 4.1 cm x 4.1 cm; 9/16 in x 1 5/8 in x 1 5/8 in
box container: 7 cm x 26.6 cm x 14.5 cm; 2 3/4 in x 10 15/32 in x 5 23/32 in
place manufactured
United States: Minnesota, Minneapolis
company location
United States: Maine, Plymouth
ID Number
2015.0031.56
catalog number
2015.0031.56
accession number
2015.0031
serial number
DEMO
model number
500DM31
serial number
000031
subject
Prosthesis
Cardiology
Artificial Organs
See more items in
Medicine and Science: Medicine
Artificial Heart Valves
Health & Medicine
Data Source
National Museum of American History, Kenneth E. Behring Center

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