Medgadget

HeartMate II Pocket Controller for Thoratec LVAD Gets U.S. Clearance

Editors — Fri, 17 May 2013 19:42:42 +0000

Thoratec received FDA clearance to offer its Pocket Controller for patients using the company’s HeartMate II LVAD (left ventricular assist device). The controller has been made lighter and smaller than previous generation models, and has an internal battery that can energize the pump at full power for 15 minutes when disconnected from the main source.

The device sounds alarms and provides on-screen instructions for what to do, but otherwise stays quietly hidden in a pant pocket.

Preventice BodyGuardian Continuous Patient Monitor Being Made Available in U.S.

Editors — Fri, 17 May 2013 15:47:42 +0000

Preventice out of Minneapolis, Minnesota, having received FDA approval last year for remote monitoring of individuals with non-lethal cardiac arrhythmias, is launching its BodyGuardian Remote Patient Monitoring System. The core technology behind the BodyGuardian was developed at the Mayo Clinic and involves processing of live data such as ECG, heart rate, heart rate variability, respiration rate, and the person’s activity level gathered from a sensor attached to the patient’s chest.

Cardiologists and other clinicians can keep a close eye on their patients throughout the day while special algorithms analyze a month’s worth of data and provide reports on patient status that would otherwise require much manual labor.

St. Jude’s ILUMIEN OPTIS PCI Optimization System with FFR, OCT Cleared in EU

Editors — Fri, 17 May 2013 15:37:07 +0000

St. Jude Medical‘s new ILUMIEN OPTIS PCI Optimization System, a tool for assessing the state of coronary arteries before stent placement, has received European approval to begin distribution on the continent.

The ILUMIEN platform combines Fractional Flow Reserve (FFR) for measuring intra-arterial pressure with intravascular Optical Coherence Tomography (OCT) for a visual look inside arteries. The new OPTIS PCI system features a new, faster laser that delivers twice the resolution of previous models and additional guidance algorithms that aid with stent placement.

Telcare BGM Cellular-Based Glucometer Coming to Europe

Editors — Fri, 17 May 2013 15:33:28 +0000

Telcare (Bethesda, MD) has announced winning European clearance to begin marketing its smartphone-like blood glucose meter, a device already approved for sale in the U.S. The glucometer has built-in cellular functionality, allowing it to send data to a central server automatically from just about anywhere.

Clinicians can view individual patient readings and track progress overtime. Moreover, they can send messages directly to the individual patient glucometers recommending changes in diet, exercise, or anything else that is appropriate. A year ago, Walt Mossberg of the Wall Street Journal, himself a type 2 diabetic, favorably reviewed the Telcare device complaining mostly only about the price and battery life.

NinePoint’s NvisionVLE Tissue Imaging System Now Available in U.S.

Editors — Thu, 16 May 2013 15:44:17 +0000

Having received FDA appropriate clearances, NinePoint Medical is now making available in the U.S. its NvisionVLE esophageal tissue imaging system. The device provides a cross-sectional view of the tissue microstructure thanks to something called OFDI (optical frequency-domain imaging), a type of Fourier-domain optical coherence tomography (OCT).

The system is primarily intended to be used in imaging upper GI for diagnosis of Barrett’s esophagus and esophageal dysplasia.

DESolve, a New Bioresorbable Coronary Scaffold from Elixir, Cleared in Europe

Editors — Thu, 16 May 2013 15:32:52 +0000

Elixir Medical Corporation (Sunnyvale, CA) won the European CE Mark to begin marketing its DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System. The device dissolves within the vessel in about a year, leaving a properly shaped lumen that no longer requires support.

Novolimus, the drug deposited on the DESolve is, according to the company, a “novel mTOR inhibitor macrocyclic lactone with anti-proliferative and anti-inflammatory properties developed by Elixir for site specific therapies.”

New Laser System to Help Surgeons Drill Through Skull with Increased Safety

Editors — Wed, 15 May 2013 19:13:06 +0000

Brain injuries and strokes can sometime require surgeons to relieve pressure on the brain by drilling burr holes through the skull using a trephine. The device is straight out of the good old days of medicine when surgical tools and torture implements were made by the same manufacturers. Yet, while even dentistry has moved on, performing burr hole craniotomies is still very much a manual cranking operation prone to causing injury and even leading to meningitis.

Researchers at Fraunhofer Institutes for Photonic Microsystems, Laser Technology, and Integrated Circuits have developed a new laser system that may soon replace the trusty trephine with a safer, more consistent option. The system uses advanced new mirrors and a femto-second laser to allow the surgeon to guide the cutting beam and penetrate the skull without causing injury.

Paper-Thin Device Performs Pulse Wave Monitoring in a Tiny Package

Editors — Wed, 15 May 2013 18:56:50 +0000

Engineers at Stanford developed a tiny new sensor that is capable of monitoring the pulse with impressive resolution. About the size of a postage stamp, the device can be worn under a bandage on one of the body spots where a pulse is easily felt.

The flexible pressure-sensitive organic thin film transistors inside the device feature “maximum sensitivity of 8.4 kPa−1, a fast response time of <10 ms, high stability over >15,000 cycles and a low power consumption of <1 mW.,” according to the study appearing in Nature Communications. These parameters allow the sensor to not only detect the main peak of the pulse, but also the recoil pressure, hence to analyze the elasticity of the arterial tree (a parameter that can change with age, with medical conditions like lupus, or in response to vasoactive medications).

Berkeley Brain Injury Detector Rivals CT in Spotting Cerebral Edema, Intracranial Hematomas

Editors — Wed, 15 May 2013 18:29:54 +0000

Suspected brain injuries can be difficult to diagnose, and expensive CT scanners are the best way to look for edemas and hematomas. But CT scanners are large, expensive, ionizing, and require specialists to operate.

Researchers at UC Berkeley have been working on developing a new brain injury detector that is cheap, easy to use, and can provide nearly immediate results. The device sends radio signals that pass through the brain and are detected using a specialty antenna. The underlying technology is called Volumetric Electromagnetic Phase Shift Spectroscopy (VEPS), and it can detect “changes in tissue properties inside the body through non-contact, multi-frequency electromagnetic measurements from the exterior of the body, and thereby provide rapid and inexpensive diagnostics,” according to Gonzalez et al. study in PLOS ONE. Changes in the signal, as compared to healthy subjects, is an indicator that something is wrong. The team worked with Mexican soldiers admitted to a hospital with suspected brain injuries, and showed that the new device matched the results obtained through CT.

Devon’s extriCARE Negative Pressure Wound Therapy CE Marked

Editors — Wed, 15 May 2013 16:14:01 +0000

Devon Medical (King of Prussia, PA) announced that its extriCARE Negative Pressure Wound Therapy (NPWT) System has been cleared in Europe for distribution. The system includes the battery powered main pump unit which creates a vacuum and the various size and shape dressings to which it connects.

The pump weighs less than a pound and can be worn by the patient in the clinic or at home during normal everyday activities. The dressings are used to create a tight seal and the negative pressure from the pump brings blood into the wound and removes exudates and debris into an attached 110cc canister.