Cardiology Archives

Magnetic Catheter Guidance System from Magnetec Gets EU Clearance

by Gene Ostrovsky on Dec 19, 2011 •

magnetecs cgci Magnetic Catheter Guidance System from Magnetec Gets EU Clearance

Magnetecs, an Inglewood, California firm, received the European CE Marking for its Robotic Catheter Guidance Control and Imaging (CGCI) System.  The technology involves eight remotely controlled electromagnets that guide the movement of a magnetically-tipped EP catheter, providing precise movement with great dexterity. The display intelligently provides validation of anatomy, EP, and precise visualization of the intended work area as well as real-time display of tool location. Automated mapping of the cardiac chamber of interest removes the repetitive task of manual mapping, thereby shortening the duration of the procedure and increasing the accuracy of the generated map. Since all the imaging, tool location and control operates in the digital realm, the entire procedure is stored and available for review and playback.

According to Josh Shachar, CEO of Magnetecs, the European regulatory decision will allow the company to apply its technology “for electrophysiology and interventional cardiology as well as additional fields of use.”

wmbenl12 Magnetic Catheter Guidance System from Magnetec Gets EU Clearance

More about the system from the product page:

The CGCI system has two standard modes of control: Manual Magnetic mode and Automatic Magnetic control mode. The joystick-controlled Manual Magnetic mode provides a responsive way to direct the catheter tip about the chamber. The Automatic Magnetic mode gives the operator point-and-click targeting of map locations. In Automatic Magnetic mode, the CGCI logic routines plan a path to the targeted location, determine the optimal contact direction, and guide the catheter tip until it makes firm and continuous tissue contact. The CGCI system uses the static map geometry to plan a guidance path that will bring the catheter tip into contact with the moving tissue as it passes through the selected map location. The CGCI then uses tissue-contact sensing filters to continue advancing the tip until continuous contact is reached over the entire cardiac cycle. If the catheter slips from the location, the tissue-contact sensing system immediately alerts the operator and the magnetic field regulator, and the tip is quickly guided back into contact at the desired tissue location. If an obstacle is detected, the location is automatically marked, and a new path is planned to tissue contact.

Press release: Magnetecs CGCI Receives CE Marking for Sales in Europe

Product page: CGCI…

Cardiac Surgery / Cardiology

Berlin Heart Excor Pediatric Heart Pump Gets FDA Approval

by Gene Ostrovsky on Dec 19, 2011
Berlin Heart Excor Pediatric Heart Pump Gets FDA Approval

Having received unanimous recommendation from its Circulatory System Devices Advisory Panel to grant a humanitarian device exemption to the Berlin Heart Excor Pediatric Ventricular Assist Device (VAD), the FDA did just that.

Here are some details from our earlier post about the study that led to the approval:

Read More

Cardiac Surgery / Cardiology / Medicine

PET Scans Spot Early Signs of Aortic Stenosis

by Gavin Corley on Dec 14, 2011
PET Scans Spot Early Signs of Aortic Stenosis

Researchers from the University of Edinburgh, Scotland have demonstrated early detection of aortic stenosis using positron emission tomography (PET) scanning and chemical tracers. The researchers used two different tracers as markers of vascular inflammation (18-fluorodeoxyglucose) and calcification (sodium 18-fluoride) in the valves of patients with aortic stenosis. The study, which was published online in the journal Circulation, aimed to assess the feasibility and reproducibility of the new PET imaging approach for the diagnosis of various degrees of aortic stenosis. The background to the study is explained in the video by Dr. Mark Dweck, one of the lead investigators of the study.

From the paper’s abstract:

Read More

Anesthesiology / Cardiology / Critical Care / Emergency Medicine / Medicine / Ob/Gyn / Radiology / Surgery

Esaote’s Latest Ultrasound Devices Coming to Market

by Gene Ostrovsky on Dec 6, 2011
Esaote's Latest Ultrasound Devices Coming to Market

Esaote is releasing two new ultrasound systems for general clinical use.

The MyLab Seven is a traditional wheeled device in a small footprint with new productivity features and the MyLab Alpha is a miniaturized laptop-like ultrasound that brings the same high quality imaging of the company’s high end systems into a small package.

Read More

Anesthesiology / Cardiology / Critical Care / Medicine / Ob/Gyn / Pediatrics

Mindray DC-T6 Ultrasound Introduced at RSNA

by Gene Ostrovsky on Dec 1, 2011
Mindray DC-T6 Ultrasound Introduced at RSNA

Mindray is unveiling a new budget conscious general purpose ultrasound at the RSNA this week.  Although designed for vascular applications, the system can be used in a variety of clinical scenarios.

The DC-T6 features a 15 inch adjustable TFT screen, up to two hours of scanning per battery charge, and common features like 4D and tissue doppler imaging, as well proprietary speckle reduction and image resolution management.

Read More

Cardiac Surgery / Cardiology

SJM Quadripolar Pacing System Gets FDA Clearance

by Gene Ostrovsky on Dec 1, 2011
SJM Quadripolar Pacing System Gets FDA Clearance

Having received European approval in September, St. Jude Medical now announced FDA clearance of its Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and the matching Quartet Left Ventricular Quadripolar Pacing Lead.  The lead features four electrodes and the CRT-D is able to take advantage of them by providing up to ten different pacing configurations.

Because the electrodes cover a greater area, precise placement of the lead is less critical as adjustments of the electrical signal can be made via software.  Like many other implantable devices from St. Jude, the Unify Quadra can wirelessly interface with the Merlin.net system for reporting both on the health of the patient and the status of the device.

Read More

Cardiology / Ob/Gyn / Radiology

Toshiba Launches Aplio 300 and 500 Ultrasound Systems

by Wouter Stomp on Nov 28, 2011
Toshiba Launches Aplio 300 and 500 Ultrasound Systems

Toshiba is launching two ultrasound systems in the United States, the Aplio 300 and 500. The Aplio 300 is a pretty standard ultrasound machine that is meant to be a clinical workhorse for all routine ultrasound exams, including radiology, OB/GYN and cardiac. It comes with Differential Tissue Harmonics (D-THI) that increases uniformity in the near and far fields, especially while scanning at increased depth. It also includes the iStyle+ Productivity Suite which minimizes the amount of keystrokes necessary to perform exams.

The Aplio 500 is the more high-end option of the two, providing more advanced visualization. Highlights are the optional Fly Thru and Smart Fusion features. Fly Thru lets you navigate through a volume data set in a way similar to that known of virtual colonoscopy, to explore cavities, ducts and vessels from the inside and in 3D. Navigation happens automatically after setting a start point anywhere in the volume to begin the autopilot function, but manual control is also possible. Fly Thru can even be performed on previously acquired 3D volume data sets and can be supplemented by the corresponding three orthogonal planes. Flights can be stored as a movie clip for later review or presentation.

Read More

Cardiac Surgery / Cardiology

World’s First MRI Compatible ICD from BIOTRONIK Gets EU Clearance

by Gene Ostrovsky on Nov 23, 2011
World's First MRI Compatible ICD from BIOTRONIK Gets EU Clearance

BIOTRONIK has received European clearance for the Lumax 740 series implantable defibrillators that have been confirmed to be MR-compatible when proper precautions are taken. The series is designed to work in tandem with BIOTRONIK’S Home Monitoring technology that can wirelessly transmit critical diagnostic data from the implant to the patient’s physician or monitoring center.

BIOTRONIK is reporting that following the approval, initial implantations of the devices were performed.

Read More

Cardiology

Boston Sci’s PROMUS Element Plus Stent Now Available in U.S.

by Gene Ostrovsky on Nov 23, 2011
Boston Sci's PROMUS Element Plus Stent Now Available in U.S.

Boston Scientific received FDA clearance and is planning to immediately begin marketing its PROMUS Element Plus Platinum Chromium Coronary Stent system. The everolimus eluting stent is essentially the combination of the PROMUS Element Stent coupled with an improved catheter delivery system.

According to Boston Sci’s CEO Hank Kucheman, the stent “marks an important milestone” because it will allow the company to manufacture its own device rather than license it from a third party.

Read More

567891011121314

Follow Medgadget on Twitter