CLEVELAND, June 18 Synapse Biomedical Inc.(www.synapsebiomedical.com) announced today it has received approval from theU.S. Food and Drug Administration (FDA) for its NeuRx DPS(TM) forventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntarycontrol of their diaphragms. With the FDA's approval, SCI patients and theircaregivers throughout the U.S. can now access this technology that waspreviously only available to clinical trial participants.
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The device implanted through minimally invasive laparoscopic surgery,provides electrical stimulation to muscle and nerves that run through thediaphragm. When stimulated by the NeuRx DPS(TM), the diaphragm contracts,mimicking natural breathing, and allows air to fill the upper and lower partsof the lungs rather than forcing air in with a mechanical ventilator.
The NeuRx DPS(TM) received the CE Mark (CE Registration #518356) onNovember 20, 2007 and is approved for treating patients with diaphragmdysfunction in the European Union. Seven successful implants have occurred atleading European hospitals including: Charite - Univeritatsmedizin (Berlin);Groupe Hospitalier Pitie-Salpetrier (Paris) and Institut GUTTMANN - HospitalDe Neuro Rehabilitacio (Barcelona) since that date.
The FDA decision was completed after clinical testing, which began withclinical trials starting in 2000 under Investigational Device Exemption#G920162.
The FDA approval is based on 50 patients implanted with the device inclinical trials at hospitals in the U.S. and Canada - University HospitalsCase Medical Center, Ohio; Shepherd Center, Atlanta, Ga.; Methodist, Houston,Texas; and Vancouver General Hospital, Vancouver. All of the implantingsurgeons were trained in the device under the direction of Dr. Raymond Onders,director of minimally invasive surgery at University Hospitals, Cleveland, anda founder, board member and shareholder of Synapse Biomedical. Dr. Onders willcontinue to proctor initial surgeries as regional trauma centers begin tooffer the NeuRx DPS(TM) to spinal cord patients.
"We are pleased the FDA has given approval to NeuRx DPS(TM) so we can nowoffer individuals throughout the United States the ability to breathe on theirown once again," said Anthony R. Ignani, Synapse President and Chief ExecutiveOfficer. "The national launch of the NeuRx DPS(TM) represents Synapse's firststep in applying its NeuRx(TM) neurostimulation platform to U.S. patients withchronic and acute respiratory insufficiency which has the promise of reducinghealthcare costs while improving outcomes."
In the clinical trial, NeuRx DPS(TM) provided 98% of SCI patients who hadbeen dependent on mechanical ventilation via a tracheostomy with analternative that allowed them to breathe normally and live more active lives.To date, over 50% were able to be completely eliminate their need formechanical ventilation.
Patients may be able to transfer from ventilator wards to home or assistedliving, and even travel. Speech patterns, often laborious and strained inventilator-dependent patients, return to normal. The senses of taste andsmell, severely diminished in ventilator-dependent patients, return.
Controlled through a four-channel battery-powered external pulsegenerator, the NeuRx DPS(TM) eliminates the need for a source of electricityand the concern for power outages. Patients and caregivers are easily trainedin the use of the NeuRx DPS(TM) reducing the need for external medicalsupervision. Elimination and reduction of the use of a mechanical ventilatoralso greatly reduces the patient's risk of a serious complication: VentilatorAcquired Pneumonia (VAP). In a peer review 2007 report in Physical Medicinean