GREENWICH, Conn., Jan. 31, 2011 /PRNewswire/ — Mederi
Therapeutics Inc. announced today that it has received FDA 510(k)
clearance for its new MDRF1 Generator.
The Mederi RF Generator powers the Stretta® System for
treatment of Gastroesophageal Reflux Disease (GERD) as well as the
Secca® System for Bowel Incontinence or Bowel Control Disorder
(BCD).
“Today’s FDA clearance of the MDRF1 is the culmination of
significant investment and design efforts by Mederi. The goal of
the MDRF1 project was to produce a system of the highest quality
and reliability to treat these two serious and debilitating
conditions,” stated Will Rutan, Mederi’s CEO. “Mederi’s new RF
generator dramatically reduces the user’s capital spending
requirements by combining two power generators into one. The MDRF1
is a smaller, lighter and highly portable radiofrequency generator
with a more intuitive user interface than its predecessors,”
continued Rutan. “The MDRF1 combines the functionality of
these earlier models into one system that powers both the Stretta
and Secca devices.”
The availability of these products represents a significant
advancement in minimally invasive options for the millions of
people who suffer from GERD or BCD. The treatments involve delivery
of radiofrequency energy to the sphincter muscles at either end of
the digestive system. Both Secca and Stretta bridge the gap between
conservative or pharmacologic therapy and invasive surgery –
giving doctors and patients an effective and less complicated
alternative.
This FDA 510(k) clearance, as well as our recently awarded CE
Mark, and ISO 13485 certification, demonstrate Mederi’s steadfast
commitment to innovation, safety and quality.
Additional information is available at www.mederitherapeutics.com.
ABOUT MEDERI
Mederi Therapeutics manufactures and markets innovative medical
devices that deliver radiofrequenc
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