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 CFI Medical
CFI Medical works collaboratively with clinicians to produce patient positioning, infection prevention and radiation protection systems designed to safeguard patients and clinicians alike. For more information about Zero-Gravity, visit http://cfimedical.com/zero-gravity.
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology. For more information about BIOTRONIK visit www.biotronik.com.
Senior Manager Communications & PR
BIOTRONIK SE & Co. KG
12359 Berlin, Germany
Tel. +49 (0) 30 68905 1414
* Measure for the radiation absorption capability of a given material, comparing it with the thickness of a layer of pure lead required to achieve the same shielding effect.