A Medical Device Daily

Advanced Neuromodulation Systems (ANS; Plano, Texas), the neuromodulation business of St. Jude Medical (St. Paul, Minnesota), has received CE-mark approval for its newest clinician programming platform, Rapid Programmer 3.0, for spinal cord stimulation (SCS), an advanced therapy for managing chronic pain.

Along with this marketing approval, ANS said it has launched an upgraded version of its rechargeable SCS device, the Eon, which features the company’s NeuroDynamix technology.

ANS said the Eon’s new microchip and enhanced software, together with Rapid Programmer 3.0, create what it terms “a sophisticated system to provide patients with customized pain coverage.”

Spinal cord stimulators such as the Eon device are used to treat patients suffering with chronic intractable pain. These devices — known as “pacemakers for pain” — interrupt the pain signals’ pathway to the brain by delivering low-intensity electrical pulses to selective nerve fibers along the spinal cord.

ANS said more than 30,000 patients worldwide have been implanted with the company’s neurostimulation systems.

Chris Chavez, president of ANS, said, “The enhanced Eon and the new Rapid Programmer platform work together as an integrated system to provide clinicians greater speed, power, efficiency and precision for helping patients address complex pain.”

Rapid Programmer 3.0 features two new technologies for delivering stimulation to pain patients. Dynamic MultiStim allows for real-time programming adjustments to multiple areas of pain, better targeting pain coverage and decreasing programming time. The company said this is especially useful when patients have complex pain patterns, such as a combination of back and leg pain.

The other new technology, Active Balancing, lets patients and clinicians easily fine-tune stimulation levels in multiple coverage areas, quickly establishing relief and giving patients sophisticated, yet easy-to-use, control over their therapy.

ANS said the upgraded Eon stimulator provides the longest time between recharges available today, giving patients added flexibility in their recharging schedule. It also has the leading power output on the market, supplying 25% more power than its predecessor.

The device also has the highest frequency capability on the market, according to the company, which said that capability allows Eon to serve patients who need higher frequencies to control their pain.

EU funds pro-angiogenesis agents

The European Union said it will award a grant of 12 million ($2.6 million) to a consortium developing a new class of pro-angiogenesis agents.

The consortium, called Vasoplus, includes Roche Diagnostics (Basel, Switzerland), Geymonat (Catania, Italy), and ThromboGenics (Leuven, Belgium) and Eurogentec (Seraing, Belgium).

The money, from the EU’s research support program, will contribute over the next two years to the further development of placental growth factor and analogues of this pro-angiogenic cytokine for treatment of ischemic heart disease, peripheral arterial occlusive disease, tissue regeneration and wound healing.

The growth factor is a homologue of vascular endothelial growth factor, but interacts with receptors with greater specificity. In vivo toxicology and safety pharmacology studies completed by ThromboGenics and Geymonat show it to be well-tolerated, even at doses much higher than needed for efficacy.

TrialStat aids CRR’s European trial

TrialStat (Ottawa, Ontario), a clinical data management company, said it has been selected by the Center for Risk Research (CRR; Montreal, Quebec) as the electronic data capture (EDC) and data management vendor for a Phase IV European study on a new treatment for pulmonary arterial hypertension.

TrialStat offers an on-demand EDC platform, ClinicalAnalytics, and a comprehensive line of data management services. CRR said ClinicalAnalytics enabled it to rapidly deploy its study in compliance with European data privacy and security regulations.

Starting in the UK and Germany, the three-year study also will take place in France, Ireland, Austria, Italy, Greece, Sweden, Finland, Netherlands, Portugal, Spain, Denmark, Belgium, Luxembourg, Iceland, Norway and Switzerland.

CRR, a wholly-owned subsidiary of LA-SER (Paris), is a research company that conducts large pharmacoepidemiological studies and provides strategic counsel to some of the world’s largest pharmaceutical and biotechnology companies.

Prochymal gets orphan drug status

Osiris Therapeutics (Baltimore) said it has received orphan drug designation from the European Medicines Agency (EMEA) for Prochymal, an adult stem cell product in Phase III pivotal trials for the treatment of acute Graft vs. Host Disease (GVHD).

In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations. Prochymal already has been granted both orphan drug and fast track status by the FDA, expediting its development.

Osiris has completed five clinical trials for Prochymal, including three Phase II trials, as well as initiating Phase III trials for both GVHD and Chrohn’s disease indications.

Prochymal is a preparation of mesenchymal stem cells especially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors.

Unisys, BSN in worldwide IT pact

Unisys (Sulzbach, Germany) reported signing a worldwide information technology outsourcing contract with BSN Medical (Hamburg, Germany), an international provider of products for wound care, orthopedics and phlebology, to provide BSN with a suite of IT services. The five-year contract has an estimated value to Unisys of $35 million.

Unisys will provide outsourcing services at 35 BSN locations worldwide, supporting 3,500 BSN staff. The services will cover SAP and non-SAP systems solutions, wide-area and local-area networking (WAN and LAN) and messaging. Unisys will also provide desktop services and a user help desk to support BSN Medical employees.

BSN is a 50/50 joint venture between Beiersdorf (Hamburg) and Smith & Nephew (London).