A Medical Device Daily

Spinal implant solutions company Paradigm Spine (New York) said it has received the CE mark for its DSS implantable dynamic spine stabilization system.

The DSS system is a pedicle screw-based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.

The first surgery involving the DSS system was performed late last month in Straubing, Germany by Rudolf Bertagnoli, MD.

The system was developed in close cooperation with Hans-Joachim Wilke, a well-known professor of biomechanics at the University of Ulm (Ulm, Germany), and Bertagnoli, described by Paradigm as "the most experienced spine arthroplasty surgeon worldwide."

The company said the modularity of the DSS system "enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system."

The dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size dynamic coupler, the posterior segmental height also can be adjusted. Meanwhile, the DSS fusion coupler provides rigid segmental fixation using the same instrument set. The use of percutaneous screw positioning facilitates a minimally invasive, muscle-sparing approach, the company said.

CEO Marc Viscogliosi said the DSS system is "one of the first truly dynamic stabilization systems because it increases segmental stiffness while controlling specific ranges of motion as the patient goes about his or her daily activities."

Wilke said, "We designed the system to focus on controlling 'active zone' motions, which are normally associated with pathologic painful arcs of motion. This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment."

Bertagnoli said, "I believe the DSS system has the potential to become an important new option in the continuum of spine care."

The DSS system is Paradigm Spine's fourth product to receive a CE mark, following the coflex interspinous implant, the DCI dynamic cervical implant and the coflex-F implant system.

BioDisc featured at 2 meetings

CryoLife's (Kennesaw, Georgia) BioDisc Nucleus Pulposus Replacement was featured at two recent medical conferences in Berlin. The device, which is undergoing clinical evaluation, is a fast-setting protein hydrogel designed to fill the void created during the removal, or discectomy, of nucleus material after a lumbar spinal disc herniation.

During a session at the Spine Technology Summit highlighting nucleus replacement technologies, Scott Capps, VP and general manager of CryoLife Europa, presented an overview on BioDisc and the company's plans for development and commercialization of the product.

At the Spine Arthroplasty Society (SAS; North Palm Beach, Florida) meeting, Douglas Wardlaw, orthopedic surgeon and principal investigator for the initial BioDisc study under way in Aberdeen, Scotland, presented a poster on the interim study results titled "Early clinical results of an in situ polymerizing protein hydrogel nuclear replacement."

The study is targeting patients with disc herniations in the lumbar spine at the L4/L5 and L5/S1 intervertebral levels, and is designed to gather initial clinical data.

Also at the SAS meeting, CryoLife conducted an industry workshop for attendees titled "BioDisc NPR: An emerging technology for nucleus pulposus replacement."

CryoLife President/CEO, Steven Anderson said, "Preliminary results show that BioDisc may have the potential to significantly reduce pain and improve function in patients with spinal disc herniations. The therapeutic goal of the BioDisc treatment is to reduce re-herniation, improve spinal stability, preserve disc height and improve range of motion."

CryoLife filed a CE-mark submission for BioDisc in February.

Coalition focuses on UK long-term care

One in five persons in the UK will develop long-term care needs, but the care system is still not fit for future generations of pensioners, says a new coalition, which late last month launched a public debate on the future of long-term care funding.

The Caring Choices coalition, run by the King's Fund, Joseph Rowntree Foundation, Help the Aged and Age Concern and supported by 11 other organizations spanning health and care, have joined forces to host seven regional debates across the UK, aimed at addressing the failings of the care system and look at potential solutions.

Caring Choices said views of the public, the elderly and their caregivers will be sought, "to determine how to reach a fairer system of paying for care in the future."

Key themes, based on evidence from a review of social care funding for older people authored by Sir Derek Wanless for the King's Fund and Joseph Rowntree Foundation's long-term care funding program, will be explored.

Those invited to each event include older people and their caregivers; care providers, commissioners and staff; and local and national policymakers. Participants will take part in an interactive voting session, the results of which will be used to encourage wider public and political debate, the coalition said.

Each event will focus on three key questions: "Who should pay for personal care?," "How do we encourage people to contribute to care costs?" and "How do we support the provision of informal care?"

King's Fund CEO Niall Dickson said, "A proper debate about roles, responsibilities and risks — and the trade-offs we are prepared to make as individuals and as a society — should make a big contribution to policy development in this important area."

Julia Unwin, director of the Joseph Rowntree Foundation, said, "We need a 'Plan B' for social care funding. The current system is neither fair, clear nor sustainable and the time has come to devise a system that is fit for the 21st century."