Archive for the 'Devices' Category

Portable Defibrillator Helps Police Officer To Save A Bellevue School Teacher

A middle-school teacher was revived after collapsing when a police officer at a Bellevue school on another call helped deploy a defibrillator. As part of a pilot program to improve heart attack survival rates, Bellevue and Kent police officers were issued portable automatic electronic defibrillators and trained in their use in March.

FDA Urgently Recalls AED Battery

The maker of a battery pack used in automated external defibrillators (AEDs) voluntarily recalled more than 5,000 of its units due to potentially fatal errors it causes in devices charged with the battery. The FDA has labeled the recall class I, reflecting the most severe warning and meaning that the affected device has a high probability of causing serious adverse events or death with use.

FDA okays expanded offering of Powerlink stent graft products

Endologix Inc, a medical device maker, said it has received approval from the US regulatory authority to market an expanded offering of its Powerlink stent graft products. Powerlink, which is an already approved endovascular stent graft, is used in the treatment of abdominal aortic aneurysm. In abdominal aortic aneurysm, the aortic wall weakens, creating a “ballooning” of the blood vessel.

Boston Scientific Launches Platinum Chromium TAXUS(R) Element(TM) Stent System

Boston ScientificBoston Scientific Corporation has announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included an indication for the treatment of diabetic patients.

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Cypher(R) Stent Beats Endeavor(R) in Recent Trial

cypher stentSORT OUT III Data Presented at American College of Cardiology reported the long-term follow-up of the largest randomized comparison between the CYPHER(R) Sirolimus-eluting Coronary Stent and Medtronic’s Endeavor(R) Stent highlighting significant and sustained clinical differences.

The findings report that the CYPHER(R) Stent was associated with significantly lower rates of death, myocardial infarction, and repeat procedures than the Endeavor(R) Stent out to 18 months. This information was also published in the Lancet Journal.

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New Smartphone App for Patients with AFib

afib educatorAF Stat™, a group of healthcare leaders and organizations working to improve the health and well-being of people affected by atrial fibrillation (AFib) has recently unveiled the “AFib Educator,” a smartphone app and desktop widget to help healthcare providers explain AFib to patients, their families and caregivers.

According to AFStat, although AFib is common, costly, progressive and often debilitating, healthcare professionals struggle to create a sense of urgency among their patients in treating the disease. They also believe that a  lack of knowledge and understanding of the disease is preventing the disease from being managed properly.

In addition, surveys indicate that healthcare providers don’t feel they have enough tools to explain the disease to their patients. Therefore, AFStat feels this new app will be of great value.

To learn more about the new app, click here.

New use of Boston Scientific devices backed by FDA

boston scientific logoA Food and Drug Administration panel unanimously voted for broader use of Boston Scientific’s cardiac resynchronization therapy defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms.

CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also benefit healthier patients.

However, the panel said that the use of the devices should only pertain to patients who have a heart problem that causes the left ventricle to contract later than the right ventricle.

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FDA Approves For Permanent Treatment Of Advanced Heart Failure Assist Device Pioneered By Texas Heart Institute At St. Luke’s Episcopal Hospital

St. Luke's Episcopal HospitalThe federal Food and Drug Administration has approved a continuous-flow heart-assist device pioneered at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) for use as a permanent treatment for advanced heart failure. The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States.

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“Nanoburrs” To Clear Arteries, Fight Heart Disease

Massachusetts Institute of Technology“Nanoburrs” are nanoparticles coated with a sticky protein that makes them cling onto artery walls while they slowly release drugs: the US researchers who are developing them hope they will one day provide an alternative to drug-releasing stents in fighting heart disease. The Massachusetts Institute of Technology, (MIT) and Harvard Medical School researchers, wrote about how they developed and tested the nanoburrs as potential drug-releasing agents for targeting and repairing damaged blood vessels.

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Abbott’s XIENCE V(R) Approved In Japan – Second Largest Drug Eluting Stent Market Worldwide

AbbottAbbott announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V (R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.

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