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    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.011"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265763923763"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_278"
                     title="FDA Okays First Percutaneous Heart Valve"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18135?impressionId=1265763923763"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve designed for implantation through a catheter in a leg vein.&lt;/p&gt;
&lt;p&gt;The device gives congenital heart defect patients with poorly functioning pulmonary valve conduits new treatment options without requiring open heart surgery.&lt;/p&gt;
&lt;p&gt;The valve does not cure the condition and may wear to the point of needing replacement over time, but a tissue valve in the device maintains proper blood flow-direction, which allows the valve to function longer than usual, an FDA statement said.&lt;/p&gt;
&lt;p&gt;Approval was based on clinical studies of 99 U.S. patients and 68 European patients.&lt;/p&gt;
&lt;p&gt;Participants showed improved heart function, and a majority noted improvements in clinical symptoms, the statement said.&lt;/p&gt;
&lt;p&gt;The limited durability of the device was similar to other existing treatments in the trial, with 21% of U.S. patients experiencing a stent fracture, the release said.&lt;/p&gt;
&lt;p&gt;Device manufacturer Medtronic must complete two postapproval studies to test long-term risks and benefits, including one study with 150 participants from the original clinical trials and more than 100 additional patients, who will each undergo a five-year evaluation.&lt;/p&gt;
&lt;p&gt;An additional condition of the device&apos;s approval is a review of healthcare professional specialization required for device implantation. The manufacturer must also maintain a database of valve recipients.&lt;/p&gt;
&lt;p&gt;The transcatheter valve was approved under the Humanitarian Device Exception (HDE) program, which supports device development for conditions affecting fewer than 4,000 people and allows approval for limited use with reasonable assurances that the device health benefit outweighs risk of injury or illness.&lt;/p&gt;
&lt;p&gt;Products with HDE approval can only be used at medical institutions under an institutional review board and cannot be sold for more than the cost of research, development, fabrication, and distribution.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_232"
                     title="FDA Gives Approval to New Heart Device"
                     score="0"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18089?impressionId=1265763923763"
                     
      &lt;p&gt;WASHINGTON -- The FDA has granted premarket approval to a second left ventricular assist system (HeartMate II).&lt;/p&gt;
&lt;p&gt;The device can now be used as destination cardiac support for patients with advanced-stage heart failure who are ineligible for transplantation. It was previously approved as an interim device for those awaiting transplantation.&lt;/p&gt;
&lt;p&gt;The approval was based on data from a two-year cohort study of 200, which randomized patients to the HeartMate II or the HeartMate XVE, the only other device approved for destination therapy, on a two-to-one basis, according to a statement from the device manufacturer Thoratec.&lt;/p&gt;
&lt;p&gt;Endpoints included survival at two years, free of debilitating stroke, and reoperation to repair or replace the device. The new device showed a 58% versus 24% two-year survival rate. Patients also experienced shorter hospital stays, lower rates of rehospitalization, and fewer reoperations annually.&lt;/p&gt;
&lt;p&gt;Patients with the HeartMate II noted an 80% increase in quality of life based on a 0% baseline, the release said.&lt;/p&gt;
&lt;p&gt;The device showed a lower rate of infection, renal failure, right heart and respiratory failure, and cardiovascular arrhythmia than its predecessor.&lt;/p&gt;
&lt;p&gt;As part of the premarket approval, Thoratec must complete a postmarket study and measure adverse effects, functional status, and quality-of-life data.&lt;/p&gt;
&lt;p&gt;The company also agreed to a second study to gather data on the relationship between bleeding, thrombosis, von Willebrand syndrome, and anticoagulation in left ventricular assist system patients.&lt;/p&gt;
&lt;p&gt;&quot;What this approval does do for the field of engineered solutions to healthcare problems is perhaps the most important aspect of this outcome. Innovation and improvements in technology continue to be made, and I am convinced that even better designs are on the horizon,&quot; Robert L. Kormos, MD, director of the Artificial Heart Program at McGowan Institute for Regenerative Medicine, said.&lt;/p&gt;
&lt;p&gt;The small size of the device allows it to be implanted in smaller patients, including many women.&lt;/p&gt;
&lt;p&gt;The device originally received premarket approval as the second bridge-to-transplantation device, after the HeartMate XVE, in 2008.&lt;/p&gt;
&lt;p&gt;Thoratec is located in Pleasanton, Ca.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_231"
                     title="FDA Adds Cardio Warnings to Weight-Loss Drug"
                     score="0"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18088?impressionId=1265763923763"
                     
      &lt;p&gt;WASHINGTON  --  The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.&lt;/p&gt;
&lt;p&gt;The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following: &lt;ul&gt; &lt;li&gt;Coronary artery disease (i.e., heart attack, angina)&lt;/li&gt; &lt;li&gt;Stroke or transient ischemic attack&lt;/li&gt; &lt;li&gt;Heart arrhythmia&lt;/li&gt; &lt;li&gt;Congestive heart failure&lt;/li&gt; &lt;li&gt;Peripheral arterial disease&lt;/li&gt; &lt;li&gt;Uncontrolled hypertension (&amp;gt;145/90 mmHg)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The initial review of sibutramine began in November 2009 when the FDA received preliminary data from the SCOUT study suggesting patients using the drug had a higher risk for cardiovascular events. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/17147&quot; target=&quot;_blank&quot;&gt;Early Data Link Diet Drug to MI, Stroke, and Cardiac Death&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Prior to review, the product label included a warning for patients with cardiovascular disease.&lt;/p&gt;
&lt;p&gt;Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed, an FDA statement said.&lt;/p&gt;
&lt;p&gt;Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk, the release said.&lt;/p&gt;
&lt;p&gt;The FDA said its review of SCOUT study data, as well as other information related to the drug&apos;s risks and benefits, is ongoing and will be followed by an open public advisory committee meeting to determine if it requires additional regulatory action.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_1_842"
                     title="Implantable Devices Take a Licking but Don&apos;t Always Keep on Ticking"
                     score="-0.005"
                     href="