BBI

The Healos bone graft substitute from Orquest (Mountain View, California) now has CE-mark clearance in Europe for use as a replacement for autograft in spinal fusion and other bone-grafting applications.

There are more than 600,000 spinal fusion procedures performed each year worldwide to treat patients suffering from debilitating back pain or injury. Autograft harvesting, usually from the hip bone, is painful, requires an additional surgical procedure and can cause chronic hip pain and deformity, a longer hospital stay and post-operative disability.

"Healos is the first real off-the-shelf alternative to the very painful procedure of cutting away the patient's own bone for use in spinal fusion surgery," said Gregory Casciaro, president and CEO at Orquest. "We believe Healos will have a huge impact on the billion-dollar bone grafting market because it improves patient well-being, reduces provider costs and is easy to use."

Sulzer Medica (Winterthur, Switzerland) launched Healos in the European Community market at the recent EuroSpine 2000 meeting in Antwerp, Belgium. In the U.S., it will be marketed by Sulzer Spine-Tech (Minneapolis, Minnesota) in conjunction with its BAK Interbody Fusion system of cage implants, and subject to FDA approval.

In new two-year data presented in Antwerp, patients treated with Healos continue to demonstrate good clinical results and to experience relief from their back pain. In addition, more than 200 patients have been treated with Healos since the beginning of 2000 in 30 hospitals across Europe. In the U.S., Healos is under clinical investigation in combination with Sulzer Spine-Tech's BAK system and has been implanted in more than 100 patients.

Sulzer Spine-Tech's new Silhouette line of pedicle screw and rod implants can be swiveled into the optimum position by the orthopedic surgeon to produce a spinal implant with twice the holding strength of competitive designs, the company said.

Fabricated in titanium, the spinal implant device uses tapered internal and external threads and is most often used in patients with scoliosis, spondylolisthesis and traumatic injuries, usually in the lower back.

NHS to invest in testing, emergency services

Within a comprehensive modernization plan, the British government plans to spend $450 million in the five-year period up to 2004 to improve oncology, renal and cardiology services in England.

Among major investment items planned by the National Health Service (NHS) are 50 new MRI units and 200 new CT scanners, as well as 45 new linear accelerators for cancer treatment. Some 450 new hemodialysis stations for kidney dialysis will be provided and 80 liquid cytology units will be installed with a capacity for screening 4 million women annually for cervical cancer.

Breast cancer screening will be extended up to age 70, instead of the present 50-to-64 range, with plans to extend screening services to include ovarian, colorectal and prostate cancers.

In cardiology, the government plans a network of rapid-access chest pain clinics and has set a target of 750 coronary artery bypass grafts (CABG) and 750 percutaneous transluminal coronary angioplasties (PTCA) per million population, compared to the current 450 and 375 per million, respectively.

In addition, the NHS plans to install 3,000 automatic external defibrillators in public places as well as training local personnel in their use.

The NHS also plans the completion of 18 new hospitals, which are scheduled to be fully operational by 2003-2004, at a cost of $3.5 billion.

Gene therapy in cystic fibrosis

Gene therapy to replace the defective cystic fibrosis transmembrane conductance regulator (CFTR) is a potential strategy for treating cystic fibrosis, but current levels of gene transfer efficiency are too low to result in clinical benefit.

Eric Alton of the National Heart and Lung Institute (London) and colleagues, both there and at the National Institute for Infectious Diseases (Tokyo), Kyushu University (Fukuoka, Japan) and DNAVEC Research Ibaraki (Japan), have used a Sendai virus (SeV) vector which boosts transfection efficiency by several log orders over cationic liposomes or adenovirus, and to levels compatible with therapeutic application.

Based on their studies, the SeV vector seems to possess valuable advantages for gene transfer to airway epithelium: its uptake is not inhibited by mucus, and it mediates gene to the cytoplasm where exogenous gene expression occurs. "The efficiency of SeV-mediated gene transfer is consistent with current views on the key barriers to airway gene transfer," Alton said. "It may allow respiratory gene therapy to pass through the current bottleneck of inefficient gene transfer."

Oxoid launches new cystic fibrosis test

Burkholderia cepacia (formerly known as Pseudomonas cepacia) is an important opportunistic pathogen that causes pulmonary infections in individuals with cystic fibrosis with potentially fatal outcomes. B. cepacia can survive and multiply in hostile environments like antiseptic and disinfectant solutions, distilled water and nebulizers. The organism also can be found in many non-sterile products used in hospitals. Better isolation of this organism is therefore important for early diagnosis in respiratory infections to ensure rapid selection of the most appropriate therapy.

Slow-growing cultures of B. cepacia can be missed on conventional media such as blood or MacConkey agar due to overgrowth by other, faster-growing organisms. By using a new selective isolation medium from Oxoid (Basingstoke, England), rapid growth of B. cepacia is encouraged, while growth of competing organisms like closely related Pseudomonas is inhibited. With positive results, the medium changes color from straw/green to pink.

S&N, Beiersdorf in joint venture

Smith & Nephew (S&N; London), the global medical devices company, and Beiersdorf AG (Hamburg, Germany), have created a global joint venture that will combine their traditional wound care, casting, bandaging and phlebology businesses and have pro forma annual sales in excess of (UK) 300 million. S & N also has agreed to acquire the advanced wound care business of Beiersdorf for (UK) 30 million in cash. Completion of each of these transactions is conditional upon standard closing conditions, including the receipt of competition clearances.

The new joint venture is scheduled to commence operations on April 2, 2001. The new business will be 50% owned by each company. It will be independently managed by a team drawn from both companies, and led by Chief Executive Graham Siddle, who until recently was group commercial director of S&N. Profits will be shared equally between the two companies.

The new business will be headquartered in Germany and will have independent sales and distribution resources in its key markets of Germany, the UK, US, France and the Netherlands. Initially, it will share the selling resources of both parents in other countries. The companies estimate that 65% of sales of the joint venture will be in Europe and 15% in the U.S. S&N makes tissue repair products, primarily in the areas of bone, joints, skin and other soft tissue.

MRSA rapid test from Mast Diagnostics

Methicillin-resistant Staphylococcus aureus (MRSA) is now being reported virtually worldwide, with varying degrees of prevalence since the first cases in the early 1960s. Of particular concern are epidemic MRSA (EMRSA) strains 15 and 16, which have emerged in the past 10 years. EMRSA-16 in particular is resistant to many anti-staphylococcal antibiotics including erythromycin, gentamicin, neomycin, ciprofloxacin and trimethoprim.

Mast Diagnostics (Bootle, England) proposes that instead of conventional methodologies such as susceptibility testing, MRSAs could be identified more precisely by directly detecting the mecA gene which codes for methicillin resistance or its product, a peptidoglycan transpeptidase called PBP2a. Detection of the mecA gene by methods such as PCR is relatively slow and generally too expensive for routine testing.

Mast Diagnostics' Mastalex-MRSA test is a sensitive, rapid, slide agglutination assay to detect PBP2a using latex sensitized with an appropriate monoclonal antibody. Test results are available within 10 minutes without any second incubation step.

New implantable port systems

Disetronic (Burgdorf, Switzerland) launched its new DiaPort percutaneous implantable port system at the recent congress of the European Association for the Study of Diabetes in Jerusalem, Israel. The company says that the DiaPort, intended for use in continuous insulin administration, is the only one of its kind in the world.

Insulin administration using the DiaPort closely mimics the physiological release of insulin because insulin is directly delivered to the liver on a continuous basis via a catheter implanted in the peritoneum or the umbilical vein. Consisting of a titanium housing, the system is implanted into subcutaneous tissue in the abdominal region, and a guiding catheter guides a membrane catheter into the peritoneum or umbilical vein.

Implanting the DiaPort is said to be straightforward, taking 20 to 30 minutes, and the membrane catheter can be changed without need for a further surgical intervention.

Another European supplier of implantable ports is Laboratoire Perouse Implant (Bornel France). Its Polysite 2000 line of implantable intravenous ports consists of a luer lock-type system, silicone septum, silicone catheter and a titanium reservoir. They are claimed to be suitable for drug delivery (as in chemotherapy), blood sampling and the delivery of fluids including nutritional fluid delivery.

Pediatric respiratory medicine update

The Spiro'R spirometer from Dyn'R (Muret, France) is used in pulmonary function testing (PFT), but with a difference. A recently developed acquisition card using FVC incentive software has been developed to simplify the conduct of PFT procedures in young children. The application program introduces animated games, similar to video games. The forced expiratory vital capacity, forced expiratory volume and other parameters are measured, with the score to be attained set by the practitioner to provide maximum motivation for the child.

Medexpo International (Milan, Italy) has launched the Babyneb Plus single-chamber ultrasonic nebulizer for drug delivery in the treatment of pulmonary diseases. The design of the unit makes it particularly suitable for use with children. An adjustable airflow, which is fan generated, directs the aerosol into the respiratory tract via mask, mouthpiece or nasal prong. The nebulizer comes complete with a brightly decorated carrier bag.

Cochlear implant technology

Conventional hearing aids worn externally or inside the ear canal help the 10% of the population with hearing problems. Unfortunately, 1% have profound hearing impairment and derive little benefit from hearing aids. If the auditory nerve is still functioning, then a cochlear implant can help.

The first cochlear implants were developed in 1978 by Med El (Innsbruck, Austria). Most of the subsequent technical problems were solved over the next 10 years, but it has taken another 10 years from that time for a commercial market for cochlear implants to develop. By the end of 1999, 25,000 devices had been implanted worldwide, with a current world production of 5,800 implants per year.

Advanced Bionics (Sylmar, California) uses an external microphone mounted behind the ear on the mastoid bone, with associated speech processing mechanism. A cochlear stimulator is implanted alongside the microphone and connected to the cochlea by fine electrode wires. The smallest implanted devices, made by Cochlear Ltd. (Lane Cove, Australia), measure only 18 mm x 16 mm x 2 mm.

The Fraunhofer Institute IMS (Duisburg, Germany), which has been closely involved with cochlear implant developments, is working on the challenge of automating the process of inserting individual electrodes into the implant; this is currently done manually. Multiple electrodes are necessary to stimulate nerves along the length of the cochlea, each of which is tuned to a different pitch of sound.

European business developments

Agfa Gaevert (Mortsel, Belgium) has acquired a majority shareholding in Quadrat (Deurle, Belgium) at an undisclosed price. The companies now plan to accelerate the integration of RIS software technology from Quadrat into Agfa's Impax PACS and further development of the electronic patient record. Agfa currently manages more than 400 picture archiving and communications system installations worldwide, with a majority in Europe. Quadrat has more than 140 RIS systems installed in Europe and internationally.

L'Air Liquide (Paris) is to acquire from Linde of Germany the Austrian medical and industrial gas production unit of AGA (Lidingo, Sweden). Disposal of this unit was a condition imposed by the European Commission competition unit on the merger between Linde and AGA. AGA Austria is located at Schwechat, near Vienna and reported 1999 revenues of around $48 million.