CFI Medical and BIOTRONIK Announce CE Mark for Zero-Gravity Suspended Radiation Protection System

Technology to Reduce Clinician Fatigue and Orthopedic Injuries Surpasses Partial Radiation Protection of Conventional Heavy Protective Apparel

FENTON, MI, US and BERLIN, Germany, October 1, 2014 –
CFI Medical, a leading manufacturer of innovative radiation protection products, announced CE (Conformité Européenne) approval for the Zero-Gravity Suspended Radiation Protection System Floor Unit today, paving the way for its widespread use internationally. BIOTRONIK, one of the world’s leading manufacturers of cardio- and endovascular medical devices, headquartered in Berlin, Germany, will continue to act as the exclusive distributor of Zero-Gravity outside North America.

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 orthopedic 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 less fatigue.

“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.

“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.

    About BIOTRONIK:

    BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.