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In August, Boston Scientific in Natick, MA, voluntarily recalled from the market its Rotablator RotaLink Advancer and RotaLink Plus rotational atherectomy systems.
According to Larry Best, a company spokesman, a part of the device responsible for securing the guidewire might not perform adequately and could be unsafe. He said the recall was due only to the advancer part of the device, which acts as an air turbine that spins the catheter, and was not due to the catheter itself. Boston Scientific said that it has undertaken a program to remedy the problem then will resume manufacturing the systems.
The latest recall follows last year’s recall of the same company’s NIR ON Ranger with Sox coronary stent system and more recent problems with its Discovery catheter. Company officials said that the RotaLink was associated with one patient death. They said that it has received six complaints about the device, out of approximately 35,000 units on the market.
Investigators at the Mayo Clinic in Rochester, MI, found that many heart patients who undergo angioplasty to open blocked arteries still take chest pain medications six months later despite the fact that their chest pain is alleviated. Researchers reviewed more than 3,800 cases and found that of the 99% who reported improvement in chest pain symptoms after angioplasty, 39% still took beta-blockers, 36% still took nitrates, and 57% still took calcium channel blockers. "There may be good reasons for continuing to take these drugs in some cases," said David Holmes, MD, a Mayo Clinic cardiologist, in a statement. "But we believe that there is the potential to save people from the side effects, costs, and inconvenience associated with taking these drugs. We plan to develop guidelines to identify which patients need to continue taking medications after successful angioplasty and which patients can safely discontinue these drugs." The study was published in a recent issue of Annals of Internal Medicine.
The Food and Drug Administration (FDA) gave clearance to Minneapolis-based Medtronic in August to market its Sigma pacemakers. According to the company, the Sigma line includes enhancements not typically found in other pacemakers, such as icon-based software for easier access to a patient’s cardiac activity, worldwide clinician and patient telephone support, and a system longevity of more than 10 years.
The FDA also approved the Voyager Aortic IntraClusion Device for stopped heart procedures. The device, manufactured by CardioThoracic Systems in Cupertino, CA, is recommended for use in mitral valve replacement and repair and arterial bypass graft surgery. According to a company statement, the Voyager enables surgeons to perform four functions through one incision, including internal aortic occlusion, arterial perfusion, antegrade cardioplegia delivery, and aortic venting, providing a less traumatic way of eliminating blood flow to the heart than procedures that require multiple incisions and external cross-clamping of the aorta.
The rates of high blood pressure awareness, treatment, and control continue to fall, according to a recent report in the September issue of Hypertension.
Investigators at the Mayo Clinic and Mayo Foundation in Rochester, MN, interviewed and measured blood pressure in more than 600 subjects, all white, randomly selected for participation in the Stroke Prevention: Assessment of Risk in a Community (SPARC) study. Overall, the team found that about half of both the men and women had blood pressures of 140/90 mm Hg or above, or reported a history of hypertension.
"This study illustrates a disturbingly low awareness and control of hypertension in a community that is socioeconomically prosperous, with easy access to both primary and tertiary medical care," the research team wrote. "Continued efforts are necessary to clarify the definition of hypertension, identify prognostic indicators for target organ damage, and heighten community awareness of the risks of increased blood pressure across the spectrum of severity."