ATS Medical was launched in 1991 under the direction of noted industry figure Manny Villafana, its founder and first CEO. The fledgling company’s goal was to advance the performance standard of mechanical heart valves. The result was the ATS Open Pivot® Heart Valve, today the growing choice of cardiac surgeons because of its distinctive design and performance. The ATS Open Pivot Heart Valve was first sold in international markets in 1992. FDA clearance to sell the valve in the United States was granted in October 2000.

The ATS Open Pivot Heart Valve was designed to be an evolutionary improvement on other available mechanical heart valves by incorporating a pivot mechanism consisting of protruding spheres on which the valve’s leaflets pivot to open and close. This unique open pivot was intended to eliminate the cavity created by the pivot of other bileaflet valves and to improve blood flow through the valve, minimizing potential for clot formation.

New management was assembled in October 2002 with Michael D. Dale assuming the position of President and Chief Executive Officer. Under his leadership and with guidance from the Board of Directors, the structure of the company and sales organization throughout the world was altered, resulting in a dramatic positive change in sales. Mr. Dale took on the additional responsibilities of Chairman of the Board in May 2004.

To date, more than 140,000 ATS Open Pivot Heart Valves have been implanted worldwide and multiple new products and services have been added to ATS Medical’s product and service offerings through acquisitions, product development or distribution agreements creating a diversified cardiac surgery-focused company. New products and services include ATS CryoMaze™ products for the ablation of cardiac arrhythmias, ATS Simulus® annuloplasty repair rings and bands and QAS (Quality Assured Services) home INR monitoring of oral anticoagulants.

Corporate Milestones

• ATS 3f® Aortic Bioprosthesis introduced for sale outside of U.S.
• Acquisition of the surgical cryoablation business of CryoCath Technologies
• ATS Simulus® Semi-Rigid Annuloplasty Ring receives FDA approval
• ATS Open Pivot® A360™ valve receives FDA approval
  
  

• Introduction of ATS Simulus™ annuloplasty rings and bands
• Acquisition of 3F Therapeutics, Inc. for tissue heart valve replacement
• ATS Open Pivot® AP360™ Heart Valve receives European CE approval
• Exclusive distribution agreement with Novare Surgical Systems, Inc. for Enclose II anastomosis assist device
  
  

• Historically recognized, 100,000 ATS Open Pivot® Heart Valves implanted
• Exclusive partnership with Regeneration Technologies, Inc.-Cardiovascular for tissue processing services
• PARSUS™ Blood filtration technology reaches second milestone in development
• Worldwide introduction of ATS Medical® Thoracic Port System for robotic surgery
• Exclusive partnership with Genesee BioMedical, Inc. for annuloplasty repair products
• Co-marketing alliance with QAS Home Monitoring for anticoagulation therapy services
  
  

• First strategic investment in PARSUS™ blood filtration technology
• Exclusive partnership with CryoCath Technologies, Inc. for surgical cryoablation treatment
  
  

• Historically recognized, 75,000 ATS Open Pivot Heart Valves implanted
• Global sales and marketing operations established for the commercialization of the ATS Open Pivot Heart Valve
  
  

• North American distribution network developed
  
  

• ATS Open Pivot Heart Valve receives FDA clearance for sale in the United States
  
  

• First ATS Open Pivot Heart Valve implanted in the U. S. by Dr. D. Nicoloff
  
  

• ATS Open Pivot Heart Valve gets European CE approval
  
  

• U. S. patent issued for the ATS Open Pivot Heart Valve
  
  

• First ATS Open Pivot Heart Valve implanted in Lausanne, Switzerland
  
  

• ATS Medical, Inc. established