CathRx files for cardiac catheters CE Mark
Wednesday, 01 March, 2006
CathRx (ASX:CXD) has taken the first step in the CE Mark approval process for its cardiac diagnostic catheters.
The company has sent a dossier to TUV, a European notified body, for regulatory approval for its modular catheters which are made up of an outer electrode sheath which contains sensors that record the heart's electrical signals. They also include and a variety of fixed curve and flexible steering mechanisms that are interchangeable and can be tailored to the particular procedure.
The next step, planned for mid 2006, is an inspection of the CathRx manufacturing facility, which would allow products to go on sale in Europe in the second half of 2006.
"This submission is a significant milestone in our plan to rollout our first products in Europe," said CathRx CEO Neil Anderson in a statement. "We anticipate the launch of our modular catheters in Europe will be through a number of distributors in various European countries. The first distributor, Cardiocare in the UK, was signed in December last year, while others are in negotiation and will be announced before sales commence."
All future catheter designs will build from this first product dossier. CathRx plans to submit a second dossier in the second quarter of 2006 for steerable versions of its catheters.
The company's shares were steady at $1.50 at the time of writing.
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