A Medical Device Daily
Tengion (East Norriton, Pennsylvania), a clinical-stage regenerative medicine company focused on the development of neo-organs and neo-tissues, reported that the European Medicines Agency (EMEA) and the European Commission (EC) have designated the Tengion Neo-Bladder Augment as an Orphan Medicinal Product for the treatment of neurogenic bladder associated with spinal cord injury.
The company said this action expands the Tengion Neo-Bladder Augment's existing orphan designation. Tengion reported in April that its Neo-Bladder Augment was granted EMEA and EC orphan designation for the treatment of neurogenic bladder in spina bifida patients.
This orphan product designation qualifies Tengion for EMEA regulatory incentives, including eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees. Orphan product designation also enables the Neo-Bladder Augment to qualify for 10 years of European marketing exclusivity upon marketing approval.
Spinal cord injuries can cause neurogenic bladder, a condition that can lead to kidney failure and incontinence, even when patients receive optimal medical treatment. Although satisfactory methods of treatment for neurogenic bladder have been authorized by EMEA, Tengion's Neo-Bladder Augment may provide significant clinical benefit to those spinal cord injury patients who suffer from neurogenic bladder and warrant surgical intervention for their condition.
"We are ... pleased that EMEA and the European Commission have further recognized the Neo-Bladder Augment's potential to significantly improve the treatment of neurogenic bladder, in this case in patients with spinal cord injury," said President/CEO Steven Nichtberger, MD. "We look forward to continuing to work with the EMEA, as well as with the FDA, to move our neo-organs through the respective regulatory pathways."
CE mark for Matrix RF applicator
Syneron Medical (Yokneam, Israel), a developer of elos combined-energy medical aesthetic devices, said it has received the CE mark for its Matrix RF applicator for use in dermatologic procedures for wrinkle reduction, by means of skin ablation and coagulation.
Matrix RF utilizes Syneron's fractional radio frequency technology to provide fractional tissue heating at three ablation and coagulation relative ratios, resulting in effective wrinkle reduction. The tunable applicator allows the user to adjust the relative ratio of ablation and coagulation, as well as direct heating, and to vary the treatment depth based upon desired clinical endpoints.
The company said the Matrix RF applicator is the first bi-polar RF non-laser and non-light-based aesthetic device capable of creating tunable ablation/coagulation impact, simulating the effects of different types of ablative/coagulative lasers used for a range of aesthetic applications.
These applications include skin rejuvenation, tightening and resurfacing and with minimal or no downtime.
Syneron said Matrix RF will be sold as an applicator add-on to all existing eLight, eLaser and eMax platforms. It said the ergonomically designed hand piece will improve ease of use for physicians performing the treatments.
Treatments will most often be performed around the eyes, mouth and cheek, but can also be performed on an entire face.