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CENTRAL PROCUREMENT AUTHORITY ANNOUNCEMENT FOR CONSULTATION RELATED TO TAVR VALVES TENDER FOR 2 YEARS IN GREECE- DEC2022

t is widely known that the hashtagTAVR market is very dynamic, and it grows around 20%+ in an annual basis in our country Greece.

Self-Expandable (SE) vs Balloon Expandable (BE) ratio is 79%-21% respectively at present in a market which is estimated to reach 1260 implants in 2022 and a value of around 19.5 million Euro.

At the same time, worldwide TAVR data based on the public earnings call of the major TAVR manufacturers is directly the opposite, with BE valves reaching 55% and SE valves 45% for a worldwide market value of around 6.25 billion USD at present for 2022.

Given the above-mentioned facts, the recent announcement coming from the National Central Procurement Authority for consultation needs adjustment and fine-tuning. Current distribution of required TAVR quantities including 90% (900 units in total) for SE valves and 10% (100 units in total) for BE valves annually for the next 2 years, gives big and solid advantage to SE valves and its manufacturers which is not proven either from multicentric worldwide clinical studies or the Greek implant ratio from unofficial registry at present.

Even if we overlook global TAVR statistics, and overtake into consideration the higher adaptation of Key Implanting Interventional Cardiologists to SE valves vs BE valves in our country and at the same time we make some assumptions how the upcoming 2 years could evolve , a more justified and objective analogy will be, to have a 70% SE- 30% BE TAVR valves at a minimum for 2023 which means 300 valves for BE category and not 100 BE valves which is today.

Some preliminary proposals that can be easily implemented without endless, bureaucratic processes and tenders for TAVR valves market selection having in mind seamless patient and Healthcare professional access to innovative technologies, and the optimal transcatheter valve selection based on patient profile and anatomy include among others:

Ø Full Harmonization of the National Reference Price List which is 18.150 per unit at present to around 15.000 Euro which is the real average market price at present. In this case the Ministry of Health shall commit on Average Payment Terms.

Ø Creation of a serious and official TAVR registry in our country with performance indicators both for the Implanting centers and the implanting valves updating with public document all the stakeholders on a quarterly basis.

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