EnteroMedics Bags CE Mark Authorization For Maestro RC System
EnteroMedics Inc., the exclusive developer of medical devices using neuroblocking tech to treat obesity and other gastrointestinal troubles, declared that it has got CE Mark authorization of its second generation Maestro® RC System for curing obesity utilizing VBLOC® vagal blocking therapy.
The Maestro RC System, a pacemaker-like appliance offers a patient-oriented obesity therapy, which affects the functioning of hunger and fullness without forcing punitive, mechanical limits to lifestyle and diet, or requiring surgical change of the anatomy.
As declared during August last year, ENteroMedics Inc. plans to market the Maestro RC System in the Australian market through an application for authorization and listing with the Australian Therapeutic Goods Administration (TGA), a procedure for which CE Mark nod is a requirement.
CE Mark is a conformity mark granted by the European Commission and recognized by many countries, comprising Australia.
With CE Mark authorization achieved, the company has decided to go ahead with its application for TGA authorization and once approval is granted, the Company anticipates first commercial sales of the Maestro System by 2011's second half.
The Company also declared that it has made entry into an exclusive, multi-year distribution deal with Device Technologies Australia Pty Limited, a major supplier of leading edge medical equipment and consumables in Australia and New Zealand, for sale and distribution of the Maestro RC System.
Device Technologies Australia Chief Executive Officer Peter Ord stated, "EnteroMedics technology is viewed as cutting edge and this partnership is an exciting move into the obesity market for Device Technologies."
EnteroMedics also declared that the Company's key ReCharge Trial remains on track, with patient enrollment and implants beginning in the first half of 2011 and enrollment completion anticipated by the end of 2011.
President and CEO Mark B. Knudson, Ph. D added, "CE Mark certification and the Australian distribution agreement represent two important milestones for the Maestro System as we look to bring this innovative technology to markets around the globe where obesity has become epidemic. Our agreement with Device Technologies Australia, a leader in medical technology distribution, allows us to immediately begin working toward our goal of commercial launch of the Maestro System in Australia, once TGA approval is granted. While we work toward this goal, we remain on-track to complete enrollment of the ReCharge Trial, the cornerstone of our U. S. commercialization strategy, by the end of 2011."