April 30, 2008 - Physio-Control Inc. has reached an agreement on a consent decree with the FDA regarding its quality system improvements for its external defibrillator products, which outlines steps the company must take to regain permission for unrestricted distribution of its external defibrillators.

April 30, 2008 - A new study indicates that use of the minimally invasive W.L. GORE TAG Thoracic Endoprosthesis to treat descending thoracic aneurysms appears to be superior to open surgical repair in anatomically suitable patients.

April 30, 2008 - Acusphere has submitted a New Drug Application (NDA) to the FDA for approval to market Imagify (Perflubutane Polymer Microspheres for Injectable Suspension), an ultrasound imaging agent for the detection of coronary artery disease, which could prove as accurate as nuclear stress testing.

The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).

April 29, 2008 - Sorin Group Cardiac Rhythm Management completed the first implant in a clinical trial of its new-generation PARADYM 8770 sonR cardiac resynchronization therapy defibrillator (CRT-D), introducing a technology based on hemodynamic response for continuous adjustment of cardiac resynchronization.

April 29, 2008 - The FDA has approved the LipiScan Coronary Imaging System, an angiography laser scanner by InfraReDx Inc., which is intended to characterize fatty deposits in coronary vessel walls using near infrared diffuse spectroscopy.

April 29, 2008 - Medtronic received CE mark approval for the Defender embolic protection filter, a device designed to get rid of emboli that can occur during a variety of stenting procedures.

April 29, 2008 - Cardium Therapeutics and its operating unit InnerCool Therapies said today that InnerCool’s endovascular Celsius Control System was featured on Science Channel’s “Cool Stuff: How It Works.”

The segment (episode 5) aired April 25, 2008, and is scheduled to be rebroadcast at 8:30 p.m. and 11:30 p.m. (ET/PT) on Friday, May 9.

April 29, 2008 - HealthEast Care System publicized The National Brain Aneurysm Center and the www.brainaneurysmcenter.org Web site, formerly the HealthEast Neurovascular Institute, focusing on complex neurovascular conditions such as aneurysm, stroke, vascular malformations, brain tumors and more.

April 29, 2008 - Nihon Kohden America Inc. said its Prefense Early Detection and Notification System received 510(k) clearance from the FDA, paving the way for its release to customers.

Prefense is designed to protect hospital patients from medical harm and enhance the efficiency of rapid response teams. Prefense is unique as it allows hospital patients to freely ambulate while measuring heart rate, blood pressure, oxygen saturation and respiration - four of the seven critical parameters that trigger a rapid response team.

April 28, 2008 - CVRx introduced a new device for high blood pressure engineered to treat hypertension patients whose conditions are not controlled by drugs, and aims to reduce systolic blood pressure.

Rheos Hypertension (HT) Therapy, which is now in clinical trials, is an implantable device and uses the body's natural blood pressure sensor (the baroreflex) to reduce blood pressure. Early hypertension clinical trial results showed a 39 mmHg reduction in systolic blood pressure at one year of use.

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