Posts Tagged ‘new device’

Medtronic Launches New Cellular Accessory For The Medtronic CareLink(R) Network

Tuesday, May 11th, 2010

Medtronic, Inc. (NYSE: MDT) announced today that it now offers the new Medtronic M-Link™ cellular accessory, which provides cardiac device patients with an option to securely send information stored in their implanted devices to their clinics via the CareLink® Network using cellular signals, rather than a telephone landline. This simplified connection to the CareLink® Network enables clinicians to remotely monitor more patients who are implanted with cardiac devices.

“The M-Link cellular accessory is making remote monitoring accessible to a greater number of eligible patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Now patients without a telephone landline have a convenient option to access the CareLink Network and take advantage of the benefits that come with remote monitoring, including fewer in-clinic visits and peace of mind from knowing their device data can be transmitted using cellular technology, without the need for a landline.”

The introduction of the M-Link cellular accessory comes on the heels of a landmark study showcasing the benefits of remote monitoring for patients and their physicians. Results from Medtronic’s CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial presented at the American College of Cardiology Scientific Sessions in March 2010 showed cardiac resynchronization therapy-defibrillator (CRT-D) and implantable cardioverter-defibrillator (ICD) patients monitored through the CareLink Network experienced a significant reduction in time from clinical event to clinical decision and also benefitted from shorter hospital stays and reduced costs per hospitalization.

The M-Link cellular accessory provides patients with a convenient option to stay connected with their clinic from home, work, or while traveling globally. The M-Link cellular accessory securely connects to any CareLink Patient Monitor and allows patients to transmit data from their implanted device directly to their clinic through the secure CareLink Network. It also allows Medtronic CareAlert® Notifications to be transmitted when any of the programmable alert conditions from a patient’s implanted device has occurred. Physicians and nurses can view the transmitted data through a secure Web site, giving them the opportunity for a “real-time” look at how the patient’s device is functioning. The information transmitted is comparable to that provided during an in-clinic device follow-up visit.

Medtronic will showcase the M-Link cellular accessory as well as its portfolio of patient management and connectivity tools that simplify a clinician’s workday at Heart Rhythm 2010 in Denver, May 12-15, 2010 (booth 503). Also, showcasing the depth and breadth of data collected through Medtronic’s CareLink Network, four poster sessions and one late-breaking clinical trial will be presented at Heart Rhythm 2010 based on aggregate, de-identified data garnered exclusively through the CareLink Network.

About the Medtronic CareLink Network

The Medtronic CareLink Network is the world’s largest and most widely used remote monitoring system for implantable cardiac device patients, with more than 4,000 clinics and 500,000 patients enrolled in 30 countries. The CareLink Network has registered more than 2 million patient data transmissions since the service’s inception in 2002.

The CareLink Network provides the most flexible alert system in the industry that offers customizable and color-coded alert notifications for devices with Conexus® Wireless Telemetry. Through this network, patient data are transmitted from their implanted device using a portable monitor through cellular signals or a standard telephone line. Within minutes, the patient’s physician and nurses can view the data on a secure Internet Web site. Available information includes, but is not limited to, arrhythmia episode reports and stored electrograms along with device integrity information.

Source
Medtronic

FDA Approves New Device for Adults with Severe and Persistent Asthma

Wednesday, April 28th, 2010

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

“The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.