Development and manufacture of heart valves, vascular allografts, aortic stent grafts and surgical adhesives
Artivion, Inc. / Jotec GmbH
Kennesaw, GA (USA) · Hechingen (DE) · Singapore · Bangkok (TH) · Valinhos/SP (BR)New on Amplifa
About Artivion
Artivion, Inc., headquartered in Kennesaw, Georgia (USA), is a medical technology company specializing in technologies for the treatment of aortic and cardiovascular diseases. The portfolio includes mechanical heart valves (On-X), aortic valve prostheses, cryo-preserved human tissue allografts (heart valves, arteries, veins, patches), aortic stent grafts such as the AMDS Hybrid Prosthesis and the NEXUS Aortic Arch System, bovine pericardial patches (PhotoFix), as well as the surgical adhesive BioGlue. The company also offers contract manufacturing of hemostatic agents and pyrolytic carbon-coated medical device components as well as in-house pathology services. The German subsidiary Jotec GmbH, based in Hechingen (Baden-Württemberg), manages the EMEA business; further branches exist in Singapore, Bangkok and Brazil. Around 1,600 employees worldwide work in development, production, quality assurance and sales. The quality management system is certified to ISO 13485:2016 and MDSAP.
- Site
- Hechingen
- Processes
- Manufacture of mechanical heart valves (On-X Heart Valve), Manufacture of aortic valve prostheses (Aortovalvular Prosthesis, On-X Ascending Aortic Prosthesis), Manufacture of sutures and surgical instruments, Manufacture of vascular implants and catheters, Manufacture of aortic stent grafts (e.g. AMDS Hybrid Prosthesis, E-Vita Open Neo, E-Xtra Design, Manufacture of cardiovascular bovine pericardial patches (PhotoFix, decellularized bovine, Manufacture of surgical adhesives (BioGlue Surgical Adhesive) incl. storage and, Contract manufacturing of hemostatic agents and pyrolytic carbon-coated
- Materials
- Bovine pericardium (decellularized), Human heart valve tissue (allograft), Human vascular tissue (artery/vein, allograft), Autologous pericardium, Polyester (synthetic graft material), Pyrolytic carbon (coating for medical device components), Human vascular tissue (artery/vein), Polyester
- Certificates
- ISO 13485:2016 / MDSAP (Medical Device Single Audit Program), AATB certificate (Association for Advancing Tissue and Biologics), Tissue Bank License State of New York, Distributor License Legend Drugs/Devices, US FDA Establishment Registration (Device & Tissue Establishment), ISO 13485:2016 / MDSAP, AATB certificate, US FDA Establishment Registration, Tissue Bank License New York
- Employees
- 1,600+ (global)
- Industries
- Medical technology (cardiovascular surgery), Treatment of aortic diseases, Tissue banking/Biologics
- 01
Design & development of medical devices
- 02
Processing of human tissue allografts (cryopreservation)
- 03
Manufacture of mechanical heart valves, stent grafts, patches and surgical
- 04
Contract manufacturing of pyrolytic carbon-coated components
- 05
Quality control and microbiology laboratories
- 06
Distribution and customer service/regulatory support
Materials and Processes
Human heart valve tissue (allograft)
Cryo-preserved heart valves (CryoValve) for valve reconstruction and the Ross procedure.
Human vascular tissue (artery/vein)
Cryo-preserved allografts (CryoArtery, CryoGraft, CryoVein) for vascular reconstructions.
Bovine pericardium (decellularized)
Base material for PhotoFix patches and the surgical adhesive BioGlue.
Polyester
Synthetic graft material for aortic stent grafts such as the AMDS Hybrid Prosthesis.
Pyrolytic carbon
Coating for components of mechanical heart valves (On-X); contract manufacturing offered.
Locations
Kennesaw, GA (USA)
USGlobal Headquarters, Design/Development, Production, QC and Microbiology Laboratories
- Materials
- Polyester, pyrolytic carbon, bovine pericardium
- QC laboratory
- Microbiology laboratory
Hechingen (DE)
DEArtivion EMEA GmbH / Jotec GmbH – EMEA/Europe business
Singapore
SGCryoLife Asia Pacific Pte Ltd – Asia-Pacific region
Bangkok (TH)
THCryoLife Medical (Thailand) Co., Ltd.
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of mechanical heart valves (On-X Heart Valve)Assembly | – | – | – | – | Pyrolytic carbon (implied by On-X Heart |
| Manufacture of aortic valve prostheses (Aortovalvular Prosthesis, On-X Ascending Aortic Prosthesis)Assembly | – | – | – | – | – |
| Manufacture of sutures and surgical instrumentsAssembly | – | – | – | – | – |
| Manufacture of vascular implants and cathetersAssembly | – | – | – | – | – |
| Manufacture of aortic stent grafts (e.g. AMDS Hybrid Prosthesis, E-Vita Open Neo, E-Xtra DesignAssembly | – | – | – | – | Polyester (graft material per patient brochure), Metal stent |
| Manufacture of cardiovascular bovine pericardial patches (PhotoFix, decellularized bovinePlastics | – | – | – | – | Bovine pericardium (decellularized) |
| Manufacture of surgical adhesives (BioGlue Surgical Adhesive) incl. storage andPlastics | – | – | – | – | – |
| Contract manufacturing of hemostatic agents and pyrolytic carbon-coatedSurface | – | – | – | – | Pyrolytic carbon (coating) |
| Processing of human cardiovascular tissue allografts (heart valves, veins, arteries, patches;Testing | – | – | – | – | Human heart valve tissue, Saphenous vein, Femoral vessels, Aortoiliac arteries, Descending thoracic aorta, Autologous pericardium |
| Cardiac pathology services (macroscopic and microscopic tissue examination,Testing | – | – | – | – | Human heart tissue |
| Design and development, production and distribution of medical devices for the treatmentEngineering | – | – | – | – | – |
Additional services
Quality & Certifications
The quality management system complies with ISO 13485:2016, MDSAP, FDA 21 CFR Part 820 (QMSR) and 21 CFR Part 1271 as well as the EU MDR (EU) 2017/745. All medical device manufacturing sites are ISO 13485 certified; QC and microbiology laboratories are part of the system.
| Evidence | Kennesaw, GA (USA) | Hechingen (DE) |
|---|---|---|
| ISO 13485:2016 / MDSAP | ||
| AATB certificate | ||
| US FDA Establishment Registration | ||
| Tissue Bank License New York |
Company History
- 1995
Founding of the in-house pathology department to support Medical Examiners and Coroners.
- 2014
J. Patrick Mackin became President & CEO (September 2014), Board Member (October 2014) and Chairman (May 2015).
- 2018
AMDS Hybrid Prosthesis approved for the first time in Canada as the 'Ascyrus Medical Dissection Stent' (November 2018); since then approx. 1,500 patients implanted.
- 2022
Transition of e-mail addresses effective 24 January 2022.
- 2023
Completion of recruitment for the PERSEVERE study (November 2023); Original Registration Date of ISO 13485/MDSAP certification with BSI (2023-10-08).
- 2023
Lance Berry assumed the role of EVP, COO and CFO on 4 December 2023.
- 2024
FDA Humanitarian Device Exemption (HDE) for the AMDS Hybrid Prosthesis (9 December 2024); John E. Davis was appointed Chief Commercial Officer (February 2024).
- 2025
Late-breaking data from the AMDS PERSEVERE study (93 participants) at the 61st Society of Thoracic Surgeons Annual Meeting (27 January 2025).
- 2026
FDA approval (PMA) of the AMDS Hybrid Prosthesis (29 June 2026).
- 2026
Completion of the acquisition of Endospan Ltd. (NEXUS Aortic Arch System) on 18 May 2026.