"No other medical device company has, to our knowledge, made such progress in what is effectively the development of a next-generation heart valve," said Eddie McDaid and Gordon Wright, managing director and chairman, respectively, of Aortech International (Bellshill, Scotland), which is developing a trileaflet heart valve using a new polymer coating developed by an Australian company, Elastomedic.
In March, Aortech paid $31 million for the 67% of Elastomedic which it did not already own. McDaid said, "We were well aware of the fact that the materials [Elast-Eon polymer coating] were being evaluated by other medical device companies. We were pushing Elastomedic, as we recognized that the timing of an acquisition of this nature would be very important." He said the trileaflet valve was ahead of all other competing new developments worldwide. The company plans to start human clinical trials in the second half of next year.
According to Mike Skalsky, managing director of Elastomedix, the Elast-Eon polymer coating prevents the clotting problems associated with other mechanical valves, and thus will reduce the need for postoperative anti-clotting drug regimes, while also having a longer predicted in situ life than tissue valves.
Aortech is planning to launch in the U.S. later this year its TruCCOMS disposable continuous output cardiac catheter measurement device which obtained FDA approval last November. Since that approval, Aortech has been conducting further clinical studies in the U.S. before marketing begins.
McDaid said, "We want to open up selected sites in order to get further clinical studies to demonstrate the benefits of the device and [to] evaluate which patients should be considered as benefitting most from its use. From our perspective, we want to ensure the uptake is fairly rapid, and we are aiming for a controlled release with sales beginning toward the end of the year."
Hemolink blood substitute in Phase III trials
Hemosol (Toronto, Ontario, Canada) has reported positive safety and effectiveness results from the use of Hemolink blood substitute in patients undergoing coronary artery bypass grafting in Phase III trials in the United Kingdom and Canada.
Preliminary results from the trials showed that the use of Hemolink was accompanied by a very low usage of donor blood transfusions, the primary set target of the trials. However, since a high rate of transfusion avoidance also was seen in the control group, further in-depth analysis is needed before definite conclusions can be drawn about Hemolink's ability to obviate the need for transfusion, according to the company. Definitive results of this further analysis are expected before the end of this month.
Hemosol expects to file for regulatory approval, initially for the Canadian market, once the additional analysis is complete.
Vascutek endovascular graft in clinical trials
Sulzer Vascutek (Inchinnan, Scotland) is a leading manufacturer of vascular prostheses that are widely used by cardiovascular surgeons in the treatment of aneurysmal or occlusive arterial disease.
A division of Sulzer Medica (Winterthur, Switzerland), Vascutek produces a range of polyester knitted and woven grafts and patches for vascular and cardiovascular use.
The latest Sulzer Vascutek product, the Anaconda endovascular graft, is intended for treating abdominal aortic aneurysms. Surgeons in Italy recently implanted the Anaconda graft successfully in the first 12 patients as part of a European trial of the device. Sulzer Medica said the Anaconda device is very flexible and specifically addresses a concern associated with other grafts which have been found to kink as the aneurysm morphology changes.Philips Intera CV enables same-day diagnosis
Philips Medical Systems (Best, the Netherlands) has added to the Intera line of magnetic resonance imaging (MRI) systems the dedicated Gyroscan Intera CV, which is designed to help diagnose cardiovascular disease more quickly, accurately and economically.
According to the company, scanning most patients can be completed in one hour and diagnosis is possible on the same day, in contrast to traditional methods of cardiovascular diagnosis which can involve ultrasound, nuclear medicine and cardiac catheterization studies, taking several days of scheduling and costing far more than one MR examination.
Philips also has added Vectorcardiogram triggering to its cardiac MRI systems to separate true ECG from distortion caused by the magnetic field and RF effects, raising triggering accuracy to almost 100%. Additionally the Intera system's MotionTrak technology allows patients to breathe normally while being examined – a plus for those cardiac patients chronically short of breath.
Wristwatch blood pressure monitor
Weinberger (Dietikon, Switzerland) has launched the Delsana RM-2000 wristwatch blood pressure monitor designed to measure blood pressure levels at home or while traveling. After attaching the cuff, measurements start automatically. As soon as a measurement is ended, blood pressure and pulse rate values are shown on the liquid crystal display. Additionally, the previous seven measurements are continuously stored. Measurements remain in the memory, together with month, date and time of recording.
Deep vein thrombosis fears
Concerns over immediate and later consequences of pulmonary embolism (PE) and post-thrombotic syndrome following deep vein thrombosis (DVT) are increasing. Patients are frequently being referred to diagnostic centers in spite of low levels of clinical suspicion. The diagnosis of thromboembolic events remains difficult for the clinician, while the use of invasive methodologies like phlebography and angiographies can be linked to an increase in morbidity and mortality risks.
Alternative noninvasive diagnostic methodologies like pulmonary scintigraphy and venous echo Doppler imaging are clearly less harmful and less expensive, but may not be accessible to the physician and may also present difficulties in interpretation.
Plasma D-Dimer measurements can exclude reliably the risk of PE and DVT. The quantitative determination of cross-linked fibrin degradation products containing D-Dimer measures fibrin formation and subsequent dissolution and helps physicians to confidently rule out the possibility of deep vein thrombosis and pulmonary embolism.
The latest D-Dimer assay available in Europe is the D-Dimer PLUS latex-enhanced turbidimetric test from the Behring Diagnostics Division of Dade Behring (Liederbach, Germany). It is designed for use on its BCS high-throughput analyzer, but will shortly also be validated for use on the BCT and Sysmex CA-1500 analyzers. D-Dimer assays also are available in Europe from Diagnostica Stago (Asni res, France), TECO Medical Instruments (Neufahrn, Germany) for use on its TEChrom IV Plus 4 channel hemostasis analyzer, and from Organon Teknika (Boxtel, the Netherlands) for use on its MDA series analyzers.
Laser angioplasty results disappoint
Ralf Koster and his team at the University Hospital Eppendorf (Hamburg, Germany) have investigated the long-term outcome in patients undergoing excimer laser coronary angioplasty (ELCA) for the treatment of in-stent restenosis.
In their study, the researchers followed 96 ELCA-treated patients with a total of 141 stents over a six-month period. Over this period, 49 patients experienced angina. Angiography showed a mean diameter stenosis of 77% before treatment and 41% after ELCA treatment. Six months later, mean diameter stenosis had grown to 60%. Half the patients had more than 70% occlusion and 10, complete occlusion.