Vascular Surgery Archive

Thursday, July 2, 2009

Smoother GORE VIABAHN Endoprosthesis Gets Approved in US

W. L. Gore & Associates just received FDA's OK to market an updated version of the firm's GORE VIABAHN® Endoprosthesis indicated for "improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference diameters ranging from 4.0 - 7.5 mm [and] in iliac artery lesions with reference vessel diameters from 4.0 – 12 mm"

The modification is a result of the precision laser trimming technology which enables the removal of excess material at the device margin, resulting in a contoured edge. The device is the only stent-graft approved by the FDA for the treatment of patients suffering from Peripheral Arterial Disease (PAD) in superficial femoral artery (SFA) lesions and iliac artery lesions. In the US alone, as many as 12 million people suffer from PAD.

The GORE VIABAHN Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The outstanding flexibility of the GORE VIABAHN Endoprothesis enables it to traverse tortuous areas of the SFA and to conform to the complex anatomy of the artery. The device was initially approved by the FDA in 2005 for treating PAD in the SFA. Later in 2007, Gore made modifications to the device which includes reducing the profile and adding a Heparin Bioactive Surface.

Product page: GORE VIABAHN® Endoprosthesis

Press release: Gore Receives FDA Approval for Modification of GORE VIABAHN® Endoprosthesis

Flashbacks Gore VIABAHN® Endroprosthesis Stent: Now Approved...

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Wednesday, June 24, 2009

Improve Your Ultrasound Skills With New SonoSite iPhone App

SonoSite has released an iPhone application, called SonoAccess™, to help clinicians improve their analytical and performance skills when using ultrasound. With the help of instructional videos and an accompanying image gallery, you can improve on your echo knowledge while on your train ride to work.

Features:

Scanning Technique Videos are designed to provide expert techniques and tips for point-of-care ultrasound applications.
Video Case Studies provide an in-depth look into specific cases that you may encounter in your practice.

Clinical Image Gallery is designed to give you a look at expert ultrasound images for anatomy recognition and as a quick comparative reference for you to compare your results to.

Quick-Start Guides are abbreviated user manuals designed to give new SonoSite users a digital roadmap of their system's controls and features to help navigate the user interface.

The Reimbursement Guides are designed to provide general coverage and payment information for diagnostic ultrasound and ultrasound-guided procedures so you have accurate coding and billing information.

The SonoAccess News Feed keeps you up-to-date on the latest SonoSite news.

Watch video here demonstrating the app...

Product page: SonoAccess™ Ultrasound iPhone App

Download link @ AppStore...

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Friday, June 19, 2009

Voice Activated SonoSite Ultrasound System Keeps Hands Free to Perform Procedures

SonoSite just released their SonoRemote for controlling the company's M-Turbo and S Series ultrasounds during interventional procedures like joint injections or central line placements. In addition to traditional style buttons, the remote control features voice recognition and can be programmed to understand commands in any language. So now you can hold the probe in one hand and the syringe in the other, and not have to fiddle with reaching over to the unit to take snapshots or change parameters.

Voice or touch activated

Programmable to your voice and language

Adjust system controls from a radius of 10 meters

No need to break the sterile field

Drop-tested to 3 feet

Works with M-Turbo® and S Series™

Press release: SonoSite Begins Customer Shipments Of Ultrasound Remote Control

Product page: SonoRemote

Flashbacks: M-Turbo™: New Portable Ultrasound from SonoSite ; SonoSite S-ICU™ Ultrasound Tool; S-Nerve™ from SonoSite; The SonoSite® MicroMaxx™; Titan

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Friday, June 12, 2009

Cook Launches Z-TRAK PLUS Introduction System for Zenith TX2 TAA

A small subset of our readers that are actually involved in endovascular aortic aneurysm repairs will be pleased to know that Cook Medical is releasing a new and improved introduction system for its Zenith TX2 TAA Endovascular Graft. The company says the new introducer, Z-TRAK PLUS, sports features that can improve "maneuverability for controllable device orientation and deployment."

The launch of the new introduction system comes as physicians are increasingly turning to thoracic endovascular repair (TEVAR) as the preferred, minimally invasive option for treating TAAs. TAAs occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, often caused by a hardening of the arteries, high blood pressure, or trauma. Aneurysms of the thoracic aorta are potentially fatal, and open surgical repair is a highly invasive procedure many TAA patients cannot survive, making TEVAR their only treatment option. Untreated, five-year survival is estimated at between 10 to 15 percent.
Cook's Zenith TX2 TAA Endovascular Graft, indicated for the treatment of descending TAA, is a tube of surgical graft material reinforced with self-expanding stainless steel Z-stents and an open stent with barbs designed to hold the device securely in place within the aorta after deployment. It is sized to the length of the thoracic aorta that needs to be covered to seal off the aneurysm. The graft is positioned in the aorta under the physician's image-guided control across the aneurysm to prevent blood flow into the aneurysm. Cook's Zenith TX2 is the only endograft with circumferentially anchoring barbs on both the proximal and distal segments of the device, which provides best-in-class fixation. Radial force from the self-expanding Z-stents enables the graft to provide an excellent seal within the patient's aorta.

Utilizing a hydrophilic-coated Cook Flexor sheath and super-elastic alloy inner cannula, Z-TRAK PLUS was designed to provide enhanced control and flexibility of entry and tracking. Cook's renowned Flexor sheath features kink-resistant tubing technology for superior flexibility and trackability during use. A semi-deployed tri-fold configuration prevents a 'wind-sock' effect during deployment, thus enabling the physician to avoid slowing or stopping of the heart.

Historically, open surgical repair has been the standard treatment for TAAs. Under this approach, the chest cavity is opened and the aorta is clamped, allowing the surgeon to sew a surgical graft into place to prevent a rupture. Surgical repairs may carry health risks for older patients as they likely suffer from other significant medical conditions.

TEVAR, a minimally invasive alternative to traditional, open surgery, involves an endograft guided into the body with a catheter to seal off the aneurysm from within. Patients undergoing TEVAR typically experience shorter recovery times and are also at a lower risk of the co-morbidities associated with open surgical repair. In particular, the Zenith TX2 device is inserted through a small incision in the groin to access the patient's femoral artery. The device is guided into position through the patient's arteries under fluoroscopy. The fabric-covered self-expanding stent-graft is then placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture. For more information, visit

Press release: New Endograft Introduction System Enhances Physicial Control During Minimally Invasive Treatment for Thoracic Aortic Aneurysms

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Emboshield NAV6 Embolic Protection System Released by Abbott

Abbott Laboratories has just released a new embolism protection system in its popular line of Emboshield NAV™ devices, all designed to be used in various stenting procedures.. The Emboshield NAV6™ is indicated "for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries."

Abbott today announced the launch of the sixth-generation Emboshield NAV6™ Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. Embolic protection systems are used during the stenting procedure to prevent particles of dislodged plaque from flowing to the brain, potentially causing an ischemic stroke. The Emboshield NAV6 is now available in the United States and Europe.

Abbott’s proprietary BareWire™ technology allows for wire movement independent of the Emboshield NAV6 filter, giving physicians an increased level of control during carotid stenting procedures.

Safety and efficacy endpoints for the Emboshield NAV6 were met in Abbott’s PROTECT clinical trial, which was designed to examine carotid artery stenting with Abbott’s Emboshield systems in patients at high risk for carotid endarterectomy (surgery). In addition to demonstrating continued improvements in outcomes for carotid stent procedures, the PROTECT study data showed a low 1.8 percent composite rate of All Stroke and Death at 30 days in 220 patients. This rate is well within American Heart Association (AHA) 30-day All Stroke and Death rate guidelines for carotid endarterectomy of 6 percent for symptomatic and 3 percent for asymptomatic patients with carotid artery disease.

Here's an animation demonstrating the placement of the system and how the thrombus filter provides safety:

Thursday, June 11, 2009

Option IVC Filter Receives FDA Approval

Angiotech Pharmaceuticals, out of Vancouver, British Columbia, just received FDA clearance for the company's Option™ IVC Filter, a device indicated for prevention of pulmonary emboli. The Option™ is one of those new types of filters that give the surgeon the opportunity to remove the device at a later time.

From the press release:

The Option IVC Filter is used for the prevention of recurrent pulmonary embolism (PE). The device is implanted, typically by interventional radiologists in a minimally invasive procedure, into the body’s inferior vena cava to prevent PE. Option is specifically designed for use as both a permanent or temporary implant (in temporary, or retrievable, indications, a physician may later perform a second surgical procedure to remove the Option IVC Filter if necessary or where mandated clinically).
The results of a recently concluded clinical trial for the Option IVC Filter were presented by the study’s Principle Investigator, Dr. Matthew Johnson, at the 34th Annual Scientific Meeting of the Society of Interventional Radiology in March of 2009. The single-arm, multicenter clinical trial, which enrolled 100 patients with a mean age of 59 years, was designed to evaluate the safety and efficacy of the Option IVC filter when used both as a permanent and temporary filter in patients at increased risk for pulmonary embolism. In the trial, clinical success, defined as placement technical success without subsequent PE, significant filter migration or embolization, symptomatic thrombosis or other complications requiring filter removal or intervention, was achieved in 88% of subjects. Retrieval success was achieved in 92% (36/39) of cases where retrieval was attempted, with a mean
implantation time in those cases of 67 days. The safety profile of the Option IVC Filter was consistent with other currently marketed IVC filters.

The Option IVC filter, developed by Rex Medical, is specifically designed to facilitate long-term retrieval post device implantation if desired or deemed necessary by the treating physician, and can be used in the following conditions: pulmonary thromboembolism when anticoagulant therapy is contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive PE, and chronic recurrent PE when anticoagulant therapy has failed or is contraindicated. The nitinol, Option™ IVC Filter, with a low profile delivery system, is designed with struts which direct clot volume into the center of the vessel for maximum dissolution and preservation of blood flow, allowing for capture of clinically significant clot and protection against PE. The selfcentering filter facilitates optimal positioning and stability within the inferior vena cava.

Press release: ANGIOTECH PHARMACEUTICALS ANNOUNCES FDA 510(K) CLEARANCE OF THE OPTION™ INFERIOR VENA CAVA FILTER...

Reprinted with permission of Angiotech Pharmaceuticals, Inc

Flashbacks: Retrievable SafeFlow IVC Filter Gets FDA Nod for Everything But Retrieval; SafeFlo IVC Filter

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Thursday, May 28, 2009

ViRob, a Cavities Crawler

At the upcoming ILSI-Biomed Israel 2009 conference (June 15-17 in Tel Aviv), researchers from the Medical Robotics Laboratory at the Israel Institute of Technology (Technion) will be showing off a microrobot called ViRob, that has only a 1millimeter diameter and can crawl through vessels and cavities, when controlled by an external magnetic field. The big idea behind the ViRob device is that it can be used to deliver pharmaceutical payloads to precise locations or pull a microcatheter through tortuous terrain.

Here's what organizers of ILSI-Biomed Israel 2009 conference tell Medgadget:

Researchers are currently examining the possibility of using ViRob as a treatment for lung cancer—the world’s deadliest cancer. ViRob could assist in targeted drug delivery to lung tumors as well as take samples from different areas within the body. In addition, a number of these micro robots could simultaneously treat a variety of metastases. Researchers also plan to install additional equipment on the robot, including cameras, miniature tongs and other miniature equipment.
ViRob measures 1 millimeter in diameter and 14 mm in its entirety was developed in the lab of Prof. Shoham in the Medical Robotics Laboratory at the Israel Institute of Technology. The robot moves using an external electromagnetic ignition system, stimulated by an electromagnetic field with frequency and volume that do not agitate the body, enabling it to maneuver in different spaces and surfaces within diverse viscous fluids. The vibration created by the magnetic field propels the robot forward, as the tiny arms protruding from a central body grip the vessel wall. A basic prototype of the ViRob, which can move as fast as 9 mm per second, has been developed thusfar.

Link: ILSI-Biomed Israel 2009...

White paper from Technion...

A few videos below the fold demonstrating the ViRob:

Thursday, May 21, 2009

Retrievable SafeFlow IVC Filter Gets FDA Nod for Everything But Retrieval

Rafael Medical Technologies Ltd., an Israeli firm, has obtained FDA approval to market its uniquely shaped IVC filter for permanent implantation in patients at risk of pulmonary embolism, according to the company. The device, first reported on by us about 3 years ago, has been available on the European market since 2004 for both permanent and retrievable indications. The filter employs the company's proprietary SPACE STATION® intravascular platform for its fixation within the vena cava.

The SafeFlo® filter is an implanted expandable metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. SafeFlo®'s design provides a double ring anchoring mechanism as an alternative to the standard strut-based designs of filters available on the market since the 1970s. This anchoring mechanism design allows for full repositioning prior to active filter detachment, providing the physician with full control of the implantation procedure.

The market clearance follows SafeFlo®'s clinical evaluation over a five-year period in a prospective, multi-center clinical study in the U.S., U.K., Austria, Greece, South Africa and Israel. According to clinical investigator, Dr. John Rundback, Director of the Interventional Institute at Holy Name Hospital in Teaneck, New Jersey and Associate Professor of Clinical Radiology at Columbia University College of Physicians and Surgeons, "Our experience with SafeFlo® has been highly rewarding. The filter's design has added flexibility to the range of deployment and maneuvering possibilities with which we are presently familiar.”

Press release: FDA Clears Rafael Medical's SafeFlo® Vena Cava Filter

Product page: SafeFlo® Vena Cava Filter

Flashback: SafeFlo® IVC Filter

(hat tip: Globes Online)

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Thursday, May 14, 2009

Digital Subtraction Angiography on a Single Image

Analyzing angiography sequences typically requires viewing a series of black and white images and noticing the differences the contrast medium created as it passed through the obstructions in the vessels. To help with visualization and to improve diagnosis, Siemens is releasing a new digital subtraction angiography (DSA) software, the syngo iFlow, that automates the process to produce a color image highlighting the path of the contrast medium.

From a Siemens press statement:

The syngo iFlow application, for example, can be used to enhance pre-procedural and post-procedural imaging of patients under treatment for leg stenosis. Flow deviations and the increased utilization of collaterals can more easily be detected prior to intervention, since anomalies more readily attract the physician's attention due to their specific colors. Following the intervention, the success of a balloon dilatation or stent implantation of a stenosis is readily visible due to the improved flow.
In order to obtain a color image, syngo iFlow takes the time to maximum opacification of each individual pixel, starting with the injection and subsequently visualizing the distribution of the contrast medium through the vessels. These time measurements are then represented by a color allowing visualization of the complete vessel tree in one image.

Press release: Siemens sets a new standard in subtraction angiography

Product brochure: syngo iFlow (PDF)

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Wednesday, May 13, 2009

BrainLab's Digital Lightbox Getting an Upgrade

BrainLab AG is planning on releasing an updated version of its Digital Lightbox multitouch clinical display. Still reminding us of a giant iPhone, the unit interfaces with EMRs to display and manipulate clinical images easily and intuitively, essentially making the keyboard or any other interface device unnecessary.

Here's what the company tells Medgadget about the new features in the latest release of the Digital Lightbox scheduled for this summer:

The new Video-input feature allows the integration of data on the Digital Lightbox, when it is located in the OR, from sources like micro-, endo- and arthroscopes; and video signals can be streamed from the OR and displayed on the Digital Lightbox when it is positioned in surgeons' offices or meeting rooms. This feature extends the range of application into new medical subspecialties, strengthening the value of Digital Lightbox as a core multi-disciplinary platform for hospital information networks.
When version 1.0 came to the market, a number of customers wanted the Digital Lightbox in rooms dedicated for teaching, patient education, tumor boards and internal meetings. The new External Display-out feature makes it possible to connect the Digital Lightbox to one or more additional displays or projectors, in or outside the room. This makes it more versatile for use in situations when large groups of medical experts come together and the even the 30" display of the Digital Lightbox isn't big enough.

Digital Lightbox also serves as the viewing display and remote control for VectorVision flex, combining an image-guided surgery platform with large-scale viewing, and fast data access and manipulation.

Here's a company video demonstrating the system:

Product page: Digital Lightbox

Flashback: Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities)

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Thursday, May 7, 2009

Abbott's New PVD Offerings

Abbott today is releasing two new products for the treatment of peripheral artery disease (aka peripheral vascular disease, PVD). The FoxCross PTA Catheter sports a small profile and a smooth surface, and the HI-TORQUE Versacore peripheral guide wire promises easier, safer navigation through challenging PVD terrain.

From an Abbott press release obtained by Medgadget:

The FoxCross PTA Catheter is used to open peripheral arteries that have become blocked with plaque. The system is available in a wide variety of diameters (3 mm to 14 mm), balloon lengths (20 mm to 120 mm), and catheter lengths (50 cm, 80 cm and 135 cm) on an over-the-wire delivery platform.
FoxCross is a highly deliverable balloon dilatation catheter designed to optimize the treatment of patients with peripheral artery disease during angioplasty procedures by incorporating the latest technological advancements, including:

- Proprietary JETCOAT™ coating that allows for smooth device movement and enhanced deliverability
- Streamlined tip and crossing profile for accessing and treating challenging lesions
- Dual-lumen shaft with large, crescent-shaped contrast lumen for rapid inflation/deflation

The HI-TORQUE Versacore peripheral guide wire is designed for routine diagnostic and device delivery in interventional procedures. Versacore features a soft, shapeable tip to provide safe access to peripheral lesions and enhanced visibility under fluoroscopy. Versacore also offers excellent torque response, enabling the device to move consistently and easily around the bends of a patient's vascular system, even when accessing the hardest-to-reach lesions.

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Monday, May 4, 2009

Magnus Operating Table from Maquet

MAQUET has just unveiled improvements to its Magnus operating table, a system that can position the patient into virtually any surgical position, and at the same time accommodate patients weighing up to 250 kilograms.

From the press release:

An optimum exposure area is achieved in combination with gravitational force and the operating table's extreme tilting and tipping functionality. The tilt angle of up to 80º and canting angle of up to 45º combined with the system's fully compatible modules open up virtually unlimited positioning possibilities. "This way a patient weighing up to 250 kilograms can be brought into any possible position. MAGNUS is thus fast approaching its vision of the "floating" patient," so Dr. Engel.
This is of particular significance when it comes to minimally invasive surgery, as it is the table's extreme tilting and tipping function that makes surgical interventions even possible on an obese patient.

With its unique height adjustment range varying between 535 mm (21 Inch) and 1235 mm (49 Inch), the MAGNUS ensures ergonomic and thus relaxed working conditions even during longer operations. The benefits of individual settings are particularly evident during laparoscopic interventions: As the MAGNUS can be lowered further than any other table the surgeon can keep his elbows positioned comfortably at his side and is not forced to revert to a tiring position. The table's unique lowering functionality makes the commonly used step stool to decrease the distance to the surgical field a thing of the past. The larger abdomens of obese patients can be operated on the MAGNUS while maintaining a relaxed and comfortable posture. In contrast to laparoscopic operations, a high table position is required for hip replacement in the dorsal position. This way, the operation which may take up to 90 minutes can be performed in an upright position. If the table cannot be adjusted to the height required, the surgeon is forced to assume a bent over posture which generally results in tension and fatigue.

Besides its settings designed to cater to various indications, the MAGNUS can optimally adjust to the height of the surgeon. The advantage of this comes to the fore when putting the table in an international context: Whereas the height of the average male in Sweden is 181.5 cm (71,4 Inch), the average male in the Philippines is less than 164 cm (64,5 Inch).

Press release (.pdf)...

MAGNUS : Product Features...

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Friday, April 17, 2009

Cook's Drug-eluting Peripheral Stent Performs Well in Large Study

Cook Medical is reporting that an international study, involving 792 patients implanted with the company's paclitaxel-coated peripheral arterial stent, has demonstrated "that 82 percent of patients who were treated... were free from reintervention at two-year follow up." The device used in the follow up is Zilver® PTX™, a drug-eluting peripheral stent (DES).

More details from the press statement issued by Cook Medical:

“These results are extremely encouraging as it's the first time paclitaxel-coated stents have been used in the treatment of blockages in arteries outside the heart,” said Zilver PTX global principal investigator, Dr. Michael Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. “Patients treated with the Zilver PTX had a very low complication rate and required fewer reinterventions.”
Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78 percent, and freedom from TLR (target lesion revascularisation) was 89 percent and 82 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months.

Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in the challenging superior femoral artery and popliteal arteries, including behind the knee locations.

“We are confident the outstanding results seen in the registry study will be reflected in the randomised Zilver PTX trial which is currently ongoing,” said Rob Lyles, global leader of Cook Medical's Peripheral Intervention products division. “Cook is committed to continually improving the efficacy and safety of our products, with the overall aim of improving patient outcomes. Our clinical research with the self-expanding, polymer-free Zilver PTX stent is demonstrating its potential benefits for patients suffering from PAD.”

In addition to the registry arm of the study, the 480 patient randomised component is designed to evaluate the Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the randomised study, 240 received the Zilver PTX DES. Enrollment in the randomised study was completed in 2008.

Press release: New Study Shows that the Zilver® PTX™ from Cook Medical Effectively Treats Blockages in Critical Thigh Artery...

Zilver PTX trial...

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Thursday, March 19, 2009

Cardinal's Endura Scrubs for the Modern Clinician

Cardinal Health is releasing a new line of clinical scrubs that the company believes will make your life safer, easier, and more comfortable. The big deal about Cardinal's Endura™ apparel line is the specialty fabric used, which is supposedly stronger and more breathable.

Some features from the product page:

Excess moisture is wicked away from your skin to keep you dry and cool, no matter what you’re doing.

Scrubs shouldn't leave you feeling restricted or confined. Endura™ scrubs move with your body and help maximize your gait and pace. In addition, the Maximum-Motion™ sleeve allows your shirt to stay tucked in even when you reach and stretch.

Our advanced, synthetic material is breathable, flexible and helps control your heat index and perspiration.

Our scrubs offer a shirt pocket and two side flanking pant pockets to tuck away the important things you want to keep close. The deep side pockets in our pants are angled to keep items in, whether you're sitting or standing.

The smooth fabric of Endura™ scrubs feels natural and soft on the skin.

People aren’t rectangular. So instead of making our scrubs rectangular, we looked at the actual dimensions of thousands of healthcare workers. The cut of our scrubs follows the natural line of your body and gets rid of the bulky feel and appearance of traditional scrubs.

A unique snap system allows you to customize pants length and avoid tripping, falling or slipping. Elastic on the waistband, in addition to a drawstring, helps position pants where you want them.

Strategically placed ventilation zones across the middle of the back and behind the knee keep you dry and comfortable.

Even after 90 washes, EnduraT scrubs are still going strong. Stronger than a brand-new pair of the top-selling traditional scrubs, in fact*. You'll also notice minimal color loss and lasting moisture-wicking abilities. The competitor's scrubs, on the other hand, typically only last 50 washes.

The top-selling traditional scrubs lose 15% lint when abraded. EnduraT scrubs lose only 1.4%, making them the lowest linting scrub on the market.

Made of the strongest material on the market, EnduraT scrubs outlast the competition. Our advanced, synthetic material is abrasion- and tear-resistant and has the most uniform strength in both directions.

EnduraT scrubs can be washed at cooler temperatures and dry faster than traditional scrubs. This requires less energy and can result in savings to your hospital.

Product page: Endura™ Performance Apparel

Press release: Cardinal Health launches new products for the operating room

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Friday, March 6, 2009

Catheter for Calcium Blocked Peripheral Vessels Gets US Green Light

ClearStream Technologies out of Wexford, Ireland has received FDA approval for its ReeKross line of catheters.

The ReeKross is used in the treatment of extreme cases of critical limb ischaemia where the lesions in the vessel have become very heavily calcified. This condition often cannot be treated using angioplasty catheters of traditional designs and materia ls because the lesion is impassable. Untreated the condit ion typically results in the amputation of the patient's lower limb.
In a recent study led by Professor Reekers of the University Hospital of Amsterdam and conducted in 5 hospitals in Holland and Ireland, the Reekross substantially outperformed all other catheters evaluated through its ability to cross these chronically blocked lesions and in the durability of the balloon. Often balloons used in these types of procedures burst due to the heavy calcification. No ReeKross balloons burst during this study.

Press release: FDA approval for ReeKross family of catheters

Product page: ReeKross

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Tuesday, March 3, 2009

MRI May Replace X-Rays for Catheterizations

German researchers have developed a new metal-free guide wire to allow for the use of MRI, instead of X-rays, for imaging the location during catheterization procedures. Clinically, the benefits of the MRI approach is that a contrast agent is not required to be injected into the patient, the precise location of the catheter's tip can be easily identified on the computer screen, and no one has to be exposed to unnecessary radiation. We think such a technique can potentially improve outcomes in coronary and general vascular caths, by improving the precision and duration of these procedures.

From Fraunhofer-Gesellschaft:

Researchers at the Fraunhofer Institute for Production Technology IPT in Aachen have now found a way of avoiding both the radiation and the contrast medium. In collaboration with colleagues at Philips and University Hospital Aachen, they have developed a guide wire made of glass-fiber-reinforced plastic. “Because the guide wire is made of plastic the imaging can be performed by magnetic resonance tomography instead of computer tomography,” says IPT scientist Adrian Schütte. “This is not possible with metal guide wires as the metal wire acts as an antenna and heats up too much – this would damage the vessels, and could cause proteins to clot.” Magnetic resonance tomography has many advantages for doctors and patients. It does not produce ionizing radiation like computer tomography, and soft tissue is clearly visible, so there is no need for a contrast medium.

For the manufacture of the two-meter guide wires the researchers use the pultrusion method, which is the standard procedure for making continuous profiles from glass-fiber-reinforced plastic. “Diameters of half a millimeter or less are required for the guide wires – that’s the absolute minimum,” explains Schütte. The new guide wires will be presented at the JEC trade fair in Paris (Hall 1, Stand T18) from March 24 to 26 and will be used in hospitals for the first time in the next few months.

Press release: Inserting catheters without X-rays

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Monday, January 5, 2009

HYPER-IMS, a Tiny Implantable Wireless Pressure Monitor

Intravascular wireless pressure monitoring sensors are nothing new. As our readers might remember , CardioMEMS Inc's EndoSure™ Wireless AAA Pressure Measurement System, a device we've seen before, has been 510(k)'ed by the FDA. Now researchers from Germany's Fraunhofer Institute for Microelectronic Circuits and Systems are reporting that they are designing a smaller, and maybe even better, intravascular arterial pressure monitoring device:

If a person’s blood flows through their arteries at too high a pressure, even when they are lying still on the sofa, they could be in danger. High blood pressure causes the heart to constantly pump at full speed, which strains both the heart and vessel walls. Drugs can provide relief, but in many cases the patient’s blood pressure is still difficult to regulate and has to be consistently monitored over a long period of time. This is a tedious process: Patients have to wear a small case containing the blood pressure meter close to their body. An inflatable sleeve on their arm records their blood pressure values, for which it is regularly pumped up and deflated. This is a burden on the patients, particularly at night. The whole process is now due to become easier thanks to a tiny implant that could replace the current method. It is being developed by Fraunhofer researchers together with the company Dr. Osypka GmbH and other partners in a BMBF-funded project called “Hyper-IMS” (Intravascular Monitoring System for Hypertension Patients).
“A doctor introduces the pressure sensor directly into the femoral artery in the groin,” explains head of department Dr. Hoc Khiem Trieu of the Fraunhofer Institute for Microelectronic Circuits and Systems IMS in Duisburg. “The sensor, which has a diameter of about one millimeter including its casing, measures the patient’s blood pressure 30 times per second. It is connected via a flexible micro-cable to a transponder unit, which is likewise implanted in the groin under the skin. This unit digitizes and encodes the data coming from the micro-sensor and transmits them to an external reading device that patients can wear like a cell phone on their belt. From there, the readings can be forwarded to a monitoring station and analyzed by the doctor.” Because the researchers use special components in CMOS technology, the system requires little energy. The micro-implants can be supplied with electricity wirelessly via coils.

Implantable pressure sensors are also suitable for other applications, such as monitoring patients suffering from cardiac insufficiency. The researchers are currently performing the first clinical trials.

Project page: HYPER-IMS...

Full story from Fraunhofer: Sensor in artery measures blood pressure...

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Amimon's High Definition Wireless Video Goes Clinical

Stryker Endoscopy is launching a wireless high definition monitor for the clinical world. Utilizing wireless technology from Israel's Amimon Inc., the monitor can receive signals up to 1080i, which means uncompromising quality in OR imaging with fewer tangled cables getting in the way.

AMIMON has granted Stryker Endoscopy exclusive access to AMIMON’s technology for the medical endoscopy market.
“Only AMIMON’s High-Definition Wireless Technology is capable of transmitting the surgical video with no perceptible lag or interference throughout the entire operating room. This will allow surgeons greater flexibility in positioning the surgical display while operating. In addition, the hospitals and surgery centers will save the hassle and cost of routing DVI cables through the ceilings and overhead booms,” said William Chang, Stryker Endoscopy’s Vice President of Research & Development and Chief Technology Officer.

AMIMON WHDI™ Technology - Overview ...

Press release: Stryker Endoscopy Launches the World's First High-Definition Wireless Surgical Display With AMIMON Inc.'s High-Definition Wireless Technology ...

Globes: Wireless video co Amimon wins deal with Stryker...

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Monday, December 22, 2008

RHEOS Device for Blood Pressure Control Undergoing New Trial

Rheos™ Baroreflex Hypertension System™
CVRx®, Inc.'s (Minneapolis, MN) carotid stimulator Rheos Baroreflex Hypertension System, a device reported on by us before, is now being investigated in a new efficacy multi-center 300-patient trial led by Columbia University Medical Center and NewYork-Presbyterian Hospital . Unlike what the press release from Columbia University states, the Rheos system has not been approved by the FDA for marketing, but rather has received an investigational IDE exemption to evaluate the safety and effectiveness of the system in treating hypertension.

From the press release by Columbia University Medical Center:

The Food and Drug Administration-approved system is implanted surgically, with minimal scarring, under the skin in the neck and electronically stimulates the receptors in the carotid sinus, the area located at the bifurcations of the carotid arteries that are responsible for regulating blood pressure.
Baroreceptors work like a thermostat that automatically turns on the air conditioning when the air temperature becomes too hot. By activating the baroreceptors and sending signals to the brain, the Rheos System causes the brain to perceive a rise in blood pressure. The brain then acts to reduce blood pressure by sending signals to the blood vessels, heart and kidneys, the major organ systems involved in the control of blood pressure.

"The system is designed to work by stimulating the baroreceptors in the carotid sinus to make it appear as if patients are more hypertensive than they really are, forcing the body to respond and lower blood pressure," said Thomas Pickering, M.D., director of the CUMC Center for Behavioral Cardiovascular Health, and the national principal investigator of the trial. "For patients who have been unsuccessful at lowering extremely high blood pressures with the current pharmacological therapies, this device may be an invaluable option."

The Rheos System includes two small stimulating devices, called "leads," which are implanted, under general anesthesia, next to the carotid sinuses located on the right and left sides of the neck. It also includes a pulse generator that is about the size of a small cell phone, which is implanted in the chest (see picture, below). The generator delivers a pulse of energy between one and 7.5 volts to the leads, which conduct the energy to the carotid baroreceptors. The baroreceptors are then activated, generating nerve impulses that travel to the cardiovascular control centers in the brain, which then slow the heart rate and cause blood vessels to dilate, reducing the amount of pressure the heart must use to pump the blood, and reducing its workload.

In an earlier feasibility trial, 59 implants were done worldwide with no unanticipated adverse device effects, including device failures, arrhythmias, postural hypotension, or stenosis of the carotid artery.

One study subject is already seeing the difference in a big way. New Jersey resident Tom Pareso volunteered to have a Rheos installed when he reached the end of his rope with four different hypertension medications that left him exhausted and tired most of the day. The 47-year-old mosquito inspector said his job isn't particularly stressful, but that his family has had a history of hypertension.

Press release: Surgical Intervention to Treat Severe Hypertension Beginning to Show Results in Clinical Trial ...

RHEOS clinical trial page...

Flashbacks: Positive Results from Trial of Rheos Baroreflex Hypertension Therapy ; Novel Device for High Blood Pressure Implanted

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