CFI Medical awarded CE mark for Zero-Gravity radiation protection system
14 October 2014
CFI Medical has received the CE mark for its Zero-Gravity Suspended Radiation Protection System Floor
Unit for protecting clinicians when using X-rays in operating
The flexible floor unit acts as a single, continuous lead barrier
that covers critical parts of the body without exerting pressure. A
body shield with 1 mm Pb equivalence and a clear acrylic head
shield with 0.5 mm Pb equivalence are suspended from a rail attached
to a wheeled base that is parked during use. This allows the
clinician to move freely within the cath lab while being fully
protected by the "floating" Zero-Gravity system.
There is growing evidence that conventional radiation protective
apparel can cause great physical stress, leading to occupational
injuries from orthopaedic problems to cumulative radiation doses.
Zero-Gravity, designed to address these concerns, was first launched
in the US in 2010 and now comprises an installed base of over 250
systems worldwide. Zero-Gravity technology eliminates painful body
strain and shields a larger percentage of the body with greater lead
equivalency, protecting the health of clinicians working with
fluoroscopy and allowing physicians to perform more procedures with
The Zero-Gravity suspended radiation protection
"We are pleased to add the CE mark for personal protection
equipment to Zero-Gravity. Combined with our relationship with
Biotronik, CFI Medical is looking forward to improving the
occupational health and safety of cath labs around the world," said
Mike Czop, President, CFI Medical.
Berlin-based Biotronik will
continue to act as the exclusive distributor of the system outside
North America. "We fully expect Zero-Gravity to become a new standard in
European and worldwide interventional labs," added Udo Tegtmeyer,
Managing Director, Biotronik. "This personal protective equipment
shows that we care about the needs of both patients and physicians.
The technology will revolutionize the cath lab setup, dramatically
reducing the occupational risks of radiation."
Following initial certification of the Zero-Gravity Floor Unit,
three ceiling-mounted configurations will be sequentially submitted
for evaluation and certification in the next few months.
Source: Biotronik press release