A Medical Device Daily
Kensey Nash (Exton, Pennsylvania) reported that it has completed a European Union study to assess the safety and performance of the company's ThromCat Thrombectomy Catheter System during percutaneous coronary intervention (PCI).
The trial enrolled more than 60 patients at seven sites in Germany, and was designed to study outcomes of patients in both acute and elective PCI settings who had thrombus present in their native coronary arteries, the company said.
The ThromCat System is a mechanical thrombectomy catheter designed to remove blood clots in patients. In Europe, it is indicated for use in coronary and certain peripheral arteries.
Hospital discharge results, presented by the company at last month's EuroPCR meeting in Barcelona, Spain, demonstrated more than 90% device success, patient safety and desired device performance, with 70% thrombus removal by volume.
Kensey Nash said the study results "also showed strong improvements to TIMI flow measurements and myocardial blush scores, with only 1.6% of the patients needing temporary pacing."
More than half of the patients enrolled had presented with an acute myocardial infarction.
Michael Haude, MD, director of Medizinische Klinik I at Lukaskrankenhaus (Neuss, Germany), served as the principal investigator for the study. "Not only did the system show itself to be safe and effective in removing thrombus in the coronary setting, it was also very easy to use," he said. "I am very appreciative of the power of this device particularly in the large coronary arteries."
The ThromCat system is a fully disposable catheter system that incorporates Kensey Nash's HeliFlex technology to flush, macerate and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal.
The company said it believes the worldwide market for thrombus removal could expand with its offering of a more simple and effective device.
The ThromCat system is sold through a direct sales force in Germany and through a distribution network covering the European Union and certain other parts of the world.
In the U.S., the device is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistula, and is sold through Kensey Nash's direct sales force.
BrainLab warns of targeting error
BrainLab (Munich, Germany) warned of malfunctions in devices that provide radiation treatments for brain cancer patients, saying the action involved a small targeting error that was "unlikely" to cause problems for patients.
The French government ordered a shutdown of the equipment following the BrainLab warning.
The company downplayed the risks. Its founder and CEO Stefan Vilsmeier told the Associated Press that the action involved a "small targeting error" that was unlikely to cause problems for patients. But a company notification sent to a U.S. provider warned that injury or death could be caused by the malfunction.
BrainLab said the malfunction was believed to have occurred in just seven models in use worldwide. News reports indicated that four hospitals in France, two in the U.S. and one in Spain have the equipment.
One report quoted an official at the Cleveland Clinic , one of the affected centers, as saying the problem involves a small aiming error that can occur when BrainLab's Novalis system is used with another manufacturer's head frame, a ring-shaped device that circles the head and is used in delivering radiation.
He said the error involves a deviation of about 1.25 mm, similar to variations inherent in the delivery system, and added that he did not believe it would lead to serious problems.
BrainLab's Vilsmeier said that because doctors typically allow a margin of error in targeting a tumor with radiation, "We don't expect any problems with the patients."
Canadian center to join EDAP study
EDAP TMS (Lyon, France) reported further acceleration of its clinical trial of Ablaterm-HIFU (high-intensity focused ultrasound) treatment of prostate cancer with the upcoming addition of McMaster University Medical Center (Hamilton, Ontario) to the list of participating sites.
HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue.
William Orovan, MD, professor and chair of the department of surgery at McMaster, has been treating Ablatherm patients at a private center since 2005. "Ablatherm-HIFU is by far the best HIFU technology available, with excellent cancer control. It has proven to be the superior HIFU device from the perspectives of precision, imaging capacity and safety," Orovan said. "The technique is simple, highly effective and clearly offers tremendous advantages.
He added, "In our experience over several hundred treatments, we are extremely pleased with the outcomes, which match the clinical data already widely reported in leading journals. Most [patients] are able to resume normal activity within 24 hours of treatment, since Ablatherm is less invasive, with fewer side-effects."
Marc Oczachowski, CEO of EDAP, said that during the recent American Urological Association (Linthicum, Maryland) congress, the company "was approached by numerous centers … about joining our study, based on the strong clinical evidence already documented from the approved use of Ablatherm-HIFU outside the U.S., where it shows more than 10 years of clear success on more than 12,000 treatments."
The Ablatherm-HIFU phases II/III clinical study is currently enrolling men diagnosed with clinical stage T1a, b or c or T2a localized prostate cancer.
SheerVision distributor in product launch
SheerVision (Rolling Hills, California) reported the product launch of the new SheerVision PowerPack by its European distributor, Kalma. Kalma has placed a new order with the company and will be introducing the PowerPack throughout Europe.
The PowerPack includes: the company's flip-up loupes combined with the FireFly LED portable light system, packaged as a complete solution in a carrying case. SheerVision makes surgical loupes and light systems for dental professionals.