In what is a thought-provoking piece, European Medical Device Technology have covered an interview with the President of a company with lofty ambitions to sell their PLLA bioabsorbable stents in Europe and elsewhere, but not in the USA, citing the existence of too many big companies as the reason.
In the article, which can be found here, Keiji Igaki, co-developer of the innovative stents and President of Kyoto Medical Planning, told Japan Medical Design & Manufacturing Technology how he and the late Hideo Tamai, a cardiologist, developed this breakthrough device.
Highlights from the interview
Summarising the answers provided during the interview with Mr Igaki
- PLLA is preferable to PGA because the latter polymer disappears too quickly.
- Absorbable stents are advantageous compared with metal because they avoid concerns about metal allergy and can be used in patients who are still growing. Also it is easier to incorporate drugs into PLLA for elution post implantation.
- The product has been CE marked since 2007 and was launched in 2009. Mr Igaki says “obtaining the CE mark is not so difficult”.
- Kyoto Medical Planning will not seek FDA approval for US marketing because it does not want to be like Gulliver in the land of the giants.
- The company is currently working on obtaining Japanese approval and aims to be on the market with a “highly improved” stent in 2014.
So CE marking’s easy and the tougher routes of seeking US and Japanese approval are not being sought except with an improved product in Japan. As Europeans, should we be concerned at the comparative ease with which such an extraordinary breakthrough product got to market or delighted that as patients we have access to what looks like a promising technology. It’s one thing to say PLLA is well characterised, but entirely another to build an expandable stent with significant post-implantation demands on it.
Source: European Medical Device Technology