Huntleigh Technology (Luton, England) is using micro-pneumatic technology to develop a portable compression device for use with airline passengers at risk of developing deep vein thrombosis (DVT) during long-distance flights.Huntleigh's Flowtron intermittent compression system, widely used to prevent DVT in hospitalized patients, consists of a compression unit connected to an inflatable cuff positioned on the calf. Huntleigh plans to develop a system compact enough to be used on board an aircraft, said Alistair McLeod, group clinical director.
Trials are under way to ascertain whether intermittent calf pressure is effective in preventing DVT at varying ambient pressures, and also whether changes in veins that occur at ground level also happen in the air. The trials will involve monitoring indicators of thrombosis, including blood chemistries in subjects in decompression chambers, as well as in a group of airline passengers, McLeod said.
Regulatory approval will be sought both for North America and Europe, as well as with appropriate civil aviation authorities.
Embroidered aneurysm stents
Custom embroidery designs seem unlikely components in medical devices, but a MedLINK collaborative project partly funded by the government of the United Kingdom has developed embroidered aneurysm stents that are customized to provide a close fit for endovascular repair of abdominal aortic aneurysms, and which can be introduced through a 7 mm catheter.
Ellis Developments (Nottingham, England), Pearsalls (Taunton, England) and Queen's Medical Centre at the University of Nottingham (Nottingham,England) have developed the production system, which relies on computed tomography imaging and special software to derive the dimensions of the aneurysm and to produce a customized embroidery design. From this, manufacturing using preformed nitinol shape-memory alloy wire embroided on fine woven polyester cloth will take less than 30 minutes to a product ready for pre-sterilization.
The system has been submitted to the UK Medical Devices Agency and clinical trials will start shortly, according to Julian Ellis of Ellis Developments. Anson Medical (Didcot, England) has worldwide marketing rights to the system.
Jomed, Aortech in stent coating deal
Jomed (Helsingborg, Sweden) has signed a 15-year, non-exclusive contract with Aortech (Bellshill, Scotland) to develop the use of the company's Elast-Eon biocompatible polymer coating with Jomed's line of stents. Jomed predicts that its first Elast-Eon coated stents could be CE marked before the end of this year.
"Jomed has carried out an extensive evaluation of Elast-Eon over the past 12 months and has determined its superior mechanical properties [compared] to other known biomaterials," said Tor Peters, president and CEO of Jomed. "We will be committing considerable resources to the development of stents, with the Elast-Eon material through the regulatory procedures and requirements for both Europe and the U.S."
Elast-Eon, a silicone/polyurethane material available in different forms with differing mechanical properties, is non-thrombotic, biocompatible and has the potential for surface covering with eluting drugs or other biomaterials, according to Eddie McDaid, Aortech's managing director.
Jomed also hopes to launch in Europe its Reitan CatheterPump left ventricular assist device (LVAD) in 1Q02, according to Peters. The Reitan CatheterPump is inserted through a 4 mm incision in the left femoral artery and up to the descending aorta. The catheter tip is deployed like an umbrella, exposing an axial flow pump. The device is intended as a bridge to recovery or transplant, rather than for permanent implantation. The first human implant was in the UK last December, and clinical trials in both the U.S. and Europe are now planned, Peters said.
Biocompatibles, British Biotech stent deal
Biocompatibles International (Farnham, England) has signed an agreement with British Biotech (Oxford, England) to develop vascular stents loaded with British Biotech's batimastat, a matrix metalloproteinase inhibitor (MMPI). This group of products is thought to be associated with the remodeling of extracellular matrix during the repair of damaged blood vessels. Inhibitors of the metalloproteinase enzymes should inhibit matrix degradation, cell migration and resultant restenosis.
Under the terms of the agreement, British Biotech will manufacture the batimastat and will fund the clinical costs of the program. Clinical trials are scheduled to start in Europe in mid-2001, with commercial launch targeted for the first half of 2003.
Biocompatibles' deal with British Biotech follows a similar deal with Abbott Laboratories (Abbott Park, Illinois) to develop a stent loaded with an unnamed proprietary Abbott antiproliferative drug.
Philips in telemedicine j-v
Philips Medical Systems (Best, the Netherlands) is setting up a joint-venture cardiology telemedicine service with SHL TeleMedicine (Tel Aviv, Israel) that will include medical call centers and remote monitoring services for patients with cardiac diseases. The service will be based on the successful business model evolved by SHL and used by more than 55,000 subscribers in Israel. Initially Philips will have 80.1% of the venture, but SHL has the option to increase its initial 19.9% to 35% at a later date. The two companies also have set up a worldwide cooperation deal in health care services.
The European joint venture covers the European Union, eastern Europe, Switzerland and Russia, but excludes Britain, Portugal and Croatia where SHL already has set up similar exclusive deals. "We believe that there is large unmet demand for personal services throughout Europe," said Hans Berella, president and CEO at Philips Medical.
New CE markings
X-Site Medical's (Blue Bell, Pennsylvania) suture-based device is designed for sealing arterial access sites after catheterization procedures. The X-Press vascular closure system works by percutaneously delivering single or multiple loops of suture across the arterial puncture, similar to the Prostar vascular closure device developed by Perclose (Menlo Park, California).
Avocet Medical's (San Jose, California) self-testing prothrombin (PT) time meter, the AvoSure PT system, monitors the time it takes for a sample of blood to clot after exposure to a coagulation-promoting agent. The AvoSure system will compete with Roche Diagnostics' (Mannheim, Germany) CoaguChek reflectance photometer, which was the first patient anticoagulant self-monitoring device and has been used extensively in Germany over the past few years.
Rapid cardiac output monitor
Innovision (Odense, Denmark) has launched in Europe its Innocor cardiac output (CO) monitor for use in monitoring the progress of patients post-myocardial infarct and in support during cardiac exercise testing. The system incorporates Inert Gas Rebreathing technology to provide CO measurements in a noninvasive and painless manner.
Using a closed rebreathing system, the monitor measures the concentration curve of the inert gas bolus used and calculates the wash-out rate which is proportional to the patient's CO. Operation is based on mathematical models and on specially developed physiological software, while the monitor uses proprietary gas analyzer technology based on photo acoustic spectroscopy, which provides a greatly improved signal-to-noise ratio.