A Medical Device Daily

Pioneer Surgical Technology's (Marquette, Michigan) European subsidiary, Pioneer BV (Driebergen, the Netherlands), said the companys BacJac Interspinous Decompression System was market-launched in Europe during this weeks International SpineWeek meeting in Geneva, Switzerland.

The BacJac system is designed to relieve pain in patients with neurogenic intermittent claudication due to lumbar spinal stenosis. IT achieves spinal decompression by limiting the symptomatic extension while maintaining physiologic motion.

Pioneer said BacJacs minimally invasive, unilateral surgical approach "reduces operating room and patient recovery time, while preserving future surgical options."

BacJac is a self-deploying, non-fusion device which is tissue-sparing and ligament-preserving. The company said that, because of its large contact area with the spinous processes and its near-physiologic modulus, the BacJac ensures "a minimal risk of subsidence."

"BacJacs ... design team included Drs. Paul Anderson of the University of Wisconsin (Madison) and Jake Timothy of Leeds General Hospital (Leeds, UK)," said Lex Giltaij, MD, VP Europe & business development at Pioneer Surgical. He added: "With the collective experience of this team, the resulting BacJac system offers the least-invasive surgical technique of any clinically proven product on the market."

Pioneer said its P3 motion-preservation products offer excellent wear resistance, established biocompatibility, biodurability and radiolucency. The presence of Pioneer BV at SpineWeek includes the European introduction of the companys signature P3 (Pioneer Peek-on-Peek) Technology.

Pioneers European subsidiary was established in August 2006 following the introduction of NuBac in Europe. Pioneer BV works with distributors in several countries in Europe, including Italy, the UK, Switzerland and the Benelux countries. The company is establishing its own sales team in Germany.

Pioneer said its articulating PEEK-on-PEEK technology, in its NuBac and cervical motion preservation series, is "the most technologically advanced design in the industry." Its portfolio of vertebral spacers, cervical plating systems and minimally invasive surgery and mini-open rod systems include trade names such as Contact, IJAK, Clarity, SlimFuse and Quantum.

Health research program launched in UK

A new research program that the UK government said will help it continue to improve public health and reduce health inequalities was unveiled by Public Health Minister Dawn Primarolo last week.

The Public Health Research Program is being established by the National Institute for Health Research (NIHR) and will evaluate a wide range of public health interventions. These could include social marketing for the promotion of safe sex, to the prevention of obesity in children, and speed bumps for the prevention of traffic accidents.

The funding for the program will rise over each of the next three years to reach £10 million a year.

The research effort has been designed to provide new knowledge on the benefits, costs, acceptability and wider effect of non-NHS interventions. The program is part of a coordinated approach to health research by the NIHR and Medical Research Council.

Primarolo said, "In order to continue improving the health and wellbeing of the people of this country, we need reliable, relevant evidence on the most effective ways of protecting from disease, preventing illness and promoting good health. The NIHR Public Health Research Program will provide policymakers, front-line professionals and members of the public with the information they need to improve health and reduce health inequalities."

The NIHR program will take applications for both primary and secondary research and for assessing those efforts at regular intervals. The first call for proposals will take place in November.

Telehealth Platform promoted by Evaware

Evaware (Douglas, Isle of Man) said its Telehealth Platform "enables clinicians to remotely monitor the vital signs of their home-based patients on an almost constant basis and automatically send alerts when any pre-determined clinical thresholds are breached."

The company said the Telehealth Platform is "easily configured to meet the needs of each individual patient and has the capability of checking a range of vital signs such as pulse rate, blood pressure, temperature, peak flow, blood glucose, weight and many other parameters regularly throughout the day and night. Whenever a pre-determined threshold is breached an alert is automatically relayed to the appropriate clinicians by e-mail or text."

Nick Dyer, managing director of Evaware, said, "Telehealth systems are becoming an essential part of the mix in healthcare services in that they keep constant surveillance on patients with long term conditions and disabilities. Our Telehealth Platform benefits patients, health authorities and doctors. Patients can be monitored far more frequently and without the need to visit their doctor or hospital; health authorities benefit from reduced admissions and costs; and doctors have [fewer] patient visits and a more manageable workload."

The RTX Telehealth Monitor supplied by Evaware is Bluetooth-enabled and integrates fully with Evawares Project E-vita Patient Record Solution, together forming the Telehealth Platform. The monitor is EU-certified and FDA-approved.

LTC moves ahead on CE-mark efforts

The Live Tissue Connect (LTC) subsidiary of CSMG Technologies (Corpus Christi, Texas) said it has completed the onsite audit portion of CE-mark registration in accordance with European Medical Device Directive-93/42/EEC.

LTC already has received ISO 13485:2003 certification for the design and manufacture of the Bipolar Forceps Systems.

Don Robbins, president/CEO of CSMG Technologies said, "Completing the onsite audit marks the second of three critical milestones towards achieving the CE mark for [the] Bipolar Sealing Forceps. The first step was the receipt of their ISO 13485:2003 Quality System Certification. As we progress through this process toward achieving the CE mark in Europe, the LTC team is developing [its] marketing and sales channels as well."

LTCs surgical tissue bonding/welding device is a platform technology that bonds and reconnects human soft tissue through fusion, in contrast with conventional wound closing devices such as sutures, staples, sealant or glues.