The H2 Total Ankle Replacement System is indicated for use as a non-cemented implant outside of the United States and as a cemented implant within the United States, to replace painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis). The Hintermann Series H2™ can also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis.
Prof. Hintermann said, “I am extremely pleased with the outcomes of the recent H2 surgeries performed, especially as the patients were able to bear their own weight just 24 hours after the devices were implanted. Adding this semi-constrained option for my patients alongside the Hintermann Series H3™* mobile-bearing prosthesis, enables me to expand patient selection for total ankle replacements.”
DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters in Raleigh, NC, and through specialized and select distributors. Sales and distribution outside of the United States will be handled through HealthLink Europe BV, from its Netherlands location, and other specialized and select distributors.
David Reicher, President and Chief Executive Officer of DTM, stated, “We anticipate a limited release of the Hintermann Series H2™ beginning in early February outside of the United States, and in late March within the United States. We have been focused on training, sales, and distribution of the Hintermann Series H2™ in markets around the world and are looking forward to a very successful launch.”