Friday, November 20, 2009
Let Draeger Polaris Be Your Guiding Light
We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.
Details from the press release:
Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.
This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.
The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.
The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.
Press release: Precision lighting with the new Dräger Polaris...
(0)
Thursday, November 19, 2009
My Lab One Portable Ultrasound from Esaote Makes Debut
At the ongoing Medica 2009 in Düsseldorf, Esaote out of Genoa, Italy is releasing a new portable ultrasound system that features a 12 inch touch screen for manipulating settings without having to use buttons. The My Lab One can be worn on a shoulder strap and is designed for mobile applications such as ambulatory anesthesia, EMT, military and sports medicine.
From the press release:
The automatic rotation of the image according to the position of the system, an ergonomic probe equipped with controls, a long life battery, all add up to making this ultrasound an extraordinary innovation in the medical system arena.MyLab One is a “dedicated” ultrasound, which reflects perfectly today’s need for diagnostic capabilities in many different fields of application: from Radiology to Cardiology, from to Orthopaedics, Anaesthesia, Sports Medicine, etc… or in first-aid, emergency, vascular screening as well as in general practices.
Press release: Esaote presents “My Lab One” Innovative “wearable” ultrasound scanner ARM HELD
Product page: Esaote ultrasound...
(0)
Wednesday, November 18, 2009
DermaStream CST for Active Wound Management
Israel21C is reporting that EnzySurge out of Rosh Ha'ayin, Israel is expecting to begin FDA approval process for the complete DermaStream CST system. The wound healing device is designed to be placed over a wound to provide continuous cleaning and washing away of debris and extravasated fluid. Although the device itself received FDA clearance, the bio-active chemical solution that it is supposed to work with it has yet to get a green light.
The patent pending DermaStream CST device provides the mechanism for EnzySurge's proprietary Continuous Streaming Therapy™ (CST). CST is a modality based on continuously streaming of fresh therapeutic solutions to the wound bed while removing exudates by vacuum assisted drainage throughout the treatment cycle. The combination of the DermaStream CSTdesign and the CST action produces negative pressure above the wound without the need for external equipment.
DermaStream is designed to ensure ongoing, uniform flow of fresh solutions over the entire wound bed
The use of therapeutic solutions allows for a broad wound management platform
DermaStreamCST vacuum assisted drainage continuously removes exudate and infectious material from the wound environment.
Gravity-induced negative pressure removes exudates including removal of loose necrotic burden
DermaStream CST is a disposable, single patient use device. It is designed to provide negative pressure above the wound bed without expensive external equipment.
Demo video of the DermaStream CST:
Product page: DermaStream CST ...
More about EnzySurge's technology from Israel21C...
Flashback: DermaStream Chronic Wound Treatment Technology
(0)
Monday, November 16, 2009
Merit Laureate Guide Wire Going to Market in US
Merit Medical Systems out South Jordan, Utah received 510(K) clearance from the FDA for the Merit Laureate hydrophilic guide wire.
"This product will be sold in both our cardiology and radiology sales points," Lampropoulos added. "Procedures that include drainage catheter access, dialysis catheter placement as well as difficult vascular access procedures commonly use hydrophilic guide wires."The Merit Laureate(TM) guide wire is fabricated from a unique core nitinol wire, covered with a urethane jacket and coated with a proprietary process that produces a slippery surface. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy.
Press release: Merit Medical Announces 510(K) Clearance for the Merit Laureate(TM) Hydrophilic Guide Wire ...
(0)
Thursday, November 12, 2009
FDA Grants Vascular Solutions Clearance for The GuideLine Catheter
US FDA has given 510(k) regulatory clearance to Vascular Solutions Inc., a 
Minneapolis, Minnesota firm, to market the GuideLiner™ catheter. The device, designed to provide a coaxial guide extension and rapid exchange for coronary or peripheral interventions, comes in 6F, 7F, 8F (Freedom Fries) sizes and is delivered through standard guide catheters, hence it allows physicians to use "standard length guidewires, balloons or stents through an existing hemostatic valve," according to the company.
From the press release:
The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”
Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”
Product brochure: GuideLiner Catheter...
Product page: GuideLiner Catheter ...
(0)
Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
(0)
Friday, October 23, 2009
Lap-Pak, a Student Designed Abdominal Retractor, On Road to Market Realization
A device developed by clinicians and students at Johns Hopkins University to move bowels out of the way in laparotomies has been licensed to Seguro Surgical, a Columbia, Maryland company. The Lap-Pak is see-through and flexible, giving you ability to quickly displace the guts without all the towels and sponges and external retractors.
The primary goal for Lap-Pak is to reduce bowel packing time by 50%. Use of Lap-pak during laparotomies ensures interoperability with retractors, facilitates monitoring of bowels, and maintains tissue temperature and hydration.The Lap-Pak device is a one-piece device constructed from a soft and flexible material that is easy to position. It contains a stable body support that evenly distributes pressure. Side and bottom flaps contour against the abdominal walls to prevent movement and allow for varied cavity sizes. The dual top flaps shield the bowels while maintaining visibility of the intestines as well as internal temperature and moisture. The product will be offered in three sizes designed to fit over 80% of adults.
Press release: Seguro Acquires Worldwide Rights to Johns Hopkins Abdominal Surgery Device...
Product page: Lap-pak...
(0)
Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
(0)
GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope
Yesterday at the Web 2.0 Summit in San Francisco, GE showed off their new 
handheld ultrasound device. The Vscan looks like a cross between an iPod and a cell phone, making it possibly the world's smallest ultrasound. Later today we'll be attending GE's healthymagination technology showcase in New York where further details and specs will hopefully become available.
For critical care clinicians, Vscan can offer an immediate look beyond patient vital signs with the potential to identify critical issues, like fluid around the heart, which could be a sign of congestive heart failure. And for cardiologists, Vscan provides a dependable visual evaluation of how well the heart is pumping at a glance, so they can treat patients more efficiently.
(0)
Tuesday, October 13, 2009
Guardian II Hemostasis Valve Gets FDA Nod
The FDA has granted approval to the Guardian II™ Hemostasis Valve produced by Zerusa, a Galway, Ireland firm. The valve, designed for easy movement of catheters and other interventional angio devices while providing hemostasis, has already been approved in Europe. The device will now be distributed in the US by Vascular Solutions out of Minneapolis, MN.
Features from the product page:
Unique Seal TechnologyProvides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
Allows separation of guidewires and other devices during complex procedures. Click-open and Click-close Design
Allows single handed operation
Unique proximal cap is easily depressed for both opening and closing the lumen.
Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases. Ergonomic Design
Practical design allows the Guardian to fit comfortably in a physician’s hand.
Subtle finger tabs have been added for improved handling characteristics.
Actual device length 92mm. 8 French Lumen
Allows multiple or large therapeutic devices to be inserted during procedures. Secure Device Lock
Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.
Here's a demo animation showing how one operates the device...
Press release: Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve...
Product page: Guardian II™...
(0)
Monday, October 5, 2009
Tiny Portable Ultrasound from SonoSite Gets US OK
SonoSite (Bothell, Washington) just announced that the company received FDA approval to market the firm's tiny NanoMaxx ultrasound system throughout the United States. Weighing in at only 6 pounds (2.7 kilo) and with a battery life of 2 operational hours, the system is truly portable for busy clinics, ambulances, emergency rooms, and elsewhere that ultrasound is needed.
The new ultra portable and one button design of the NanoMaxx system makes high quality ultrasound available to a much broader range of clinicians. The system incorporates SonoSite’s advanced proprietary imaging algorithms, including SonoMB™ and SonoAdapt™ to deliver superior image quality in a lightweight, rugged form factor.With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.
At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.
For convenience and flexibility, the system can be wall mounted, placed on an exam table with kickstand attached, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.
The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, plus magnesium outer shell, allows it to be used in the most demanding and austere environments. Proving its reliability, the NanoMaxx system and its transducers successfully passed SonoSite’s standard three foot durability drop test.
In addition, to further reduce the risk of infection, the NanoMaxx system’s fluid-resistant user interface makes the system easy to clean and disinfect, helping to address the growing concern over infection control in the medical community.
Press release: SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool
Product page: NanoMaxx
Flashback: NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled
(0)
Wednesday, September 23, 2009
Cook's New IVC Filter Placement System Unveiled
Cook Medical is introducing the NavAlign IVC filter delivery system at the TCT2009 
(Transcatheter Cardiovascular Therapeutics) conference in San Francisco this week. The company promises easier deployment and reduced trauma when an inferior vena cava filter is being placed to prevent pulmonary embolism.
The NavAlign delivery system, available for both the Cook Celect® and Günther Tulip™ filters, is designed to minimize trauma and streamline filter placement with features unavailable on any other existing deployment system. A hemostatic valve minimizes blood loss at the point of entry, while a multipurpose dilator has radiopaque sizing bands and flushing sideports that decrease fluoroscopy time and the amount of contrast medium required.
Press release: Cook Medical's Advanced NavAlign™ Delivery System for IVC Filters Adds Procedural Speed, Control and Accuracy...
(0)
Monday, September 21, 2009
New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal
Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant 
for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.
LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.
Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.
LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.
Links: Lifebond technology page; LifeSeal SLR; LifeSeal Surgery
(hat tip: ISRAEL21c)
(0)
Thursday, August 13, 2009
Zilver PTX Drug Eluting Stent for Peripheral Artery Disease Gets European Approval
Cook Medical has received EU's CE Mark to market the Zilver® PTX® paclitaxel eluting nitinol stent for the treatment of peripheral artery disease in the superficial femoral artery. The paclitaxel, a drug also used in the TAXUS cardiac stents by Boston Scientific, has been licensed from Angiotech. The interesting thing about the Zilver® PTX® is that the paclitaxel is attached to to the nitinol frame without the use of any polymer or other anchoring agent, which avoids leaving any plastics behind in the vessel once paclitaxel dissolves.
From Cook's announcement of the approval:
The CE Mark follows the world's largest-ever clinical trial for a peripheral stent, led by 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, Palo Alto, California. The data published in the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and Korea and demonstrated highly positive results. Only 8 percent of all patients with de novo (new) lesions needed a reintervention to reopen the artery in the first 12 months — a rate significantly surpassing existing treatments for PAD in the SFA, such as balloon angioplasty and bare metal (non-drug-eluting) stents.Also, specific patient groups that are often very hard to treat, such as diabetics and patients with in-stent restenosis (those treated previously with a noncoated stent), were shown in the trial to benefit from the Zilver PTX. As the trial data indicate, the superior results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone. In comparisons with other trial data obtained, the Zilver PTX stent showed a reduction in reintervention of between 50 percent and 75 percent, an important patient benefit.
Cook press release: Breakthrough Drug-Eluting Stent to Treat Peripheral Artery Disease Now Available in Europe ...
Angiotech press release: ANGIOTECH'S LICENSEE, COOK MEDICAL, ANNOUNCES CE MARK APPROVAL AND EUROPEAN LAUNCH OF THE ZILVER PTX STENT
(0)
Tuesday, July 28, 2009
Cook's TX2 Pro-Form Thoracic Endograft Gets US Green Light
Cook Medical has received FDA approval to market the Zenith TX2 TAA Pro-Form endovascular graft.
Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall. This innovation in endovascular TAA repair was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are notoriously difficult to seal properly.Many earlier endografts were too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches, preventing the graft from properly sealing off the aneurysm. Consequently, surgeons have historically been forced to remodel the arch with a balloon or use other aids to position the graft, in an effort to reduce the risk of continued bleeding into the aneurysm and possible rupture. As a result, these difficult repair procedures are often long and complex. The TX2 Pro-Form’s enhanced delivery system may mitigate the need for such additional measures.
Product page: Cook Zenith....
(0)
Wednesday, July 22, 2009
Large Diameter VIABAHN Endovascular Stents Approved in US
W. L. Gore & Associates has received FDA approval for the large size VIABAHN endoprosthesis for use in iliac arteries. The stents feature a heparinized surface for a localized anti-coagulation effect.
The next generation of the large diameter product enables streamlined deployment on the same 0.035” guidewire and TIP to HUB direction as the 5 – 8 mm sizes. Additional modifications to the large diameter GORE VIABAHN Endoprosthesis include radial device expansion, a contoured proximal edge and a lower profile that is now available for most sizes.The GORE VIABAHN Endoprosthesis family of devices is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The product’s flexibility enables it to traverse tortuous areas and to conform to the complex anatomy of the artery.
Press release: Gore Receives FDA Approval for Next Generation of Large Diameter GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface...
Flashbacks: Smoother GORE VIABAHN Endoprosthesis Gets Approved in US; Gore VIABAHN Endroprosthesis Stent: Now Approved
(0)
Friday, July 17, 2009
First Atherectomy Performed With Spectranetics' Turbo-Tandem Device
Spectranetics out of Colorado Springs, Colorado has just announced the first clinical use of the company's new Turbo-Tandem™ System for removal of calcified plaques in obstructed infrainguinal arteries. The system has already received US and EU approval, and the company will be rolling out the product for global sales.
The Turbo-Tandem System is a single-use, disposable device indicated for atherectomy of infrainguinal arteries. It is comprised of two integrated catheters, a 7 French laser guide catheter in combination with a 2.0mm excimer laser ablation catheter, and is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries.The first procedure in the EU took place on July 6th at Park-Krankenhaus Leipzig-Sudost GmbH in Leipzig, Germany and was performed by Dr. med. Matthias Ulrich in collaboration with Professor Dr. med. Dierk Scheinert. A 23 cm restenotic obstruction in the proximal superficial femoral artery was treated with a Spectranetics Turbo Elite® 2.0mm excimer laser catheter to create a pilot channel through the occlusion, followed by four passes of the Turbo-Tandem to atherectomize the two separate target treatment segments. After completion of the laser atherectomy and adjunct angioplasty, distal runoff was excellent with brisk TIMI 3 blood flow and no evidence of embolic impact. Following the procedure, Dr. Ulrich and Professor Scheinert commented: "The newly integrated Turbo-Tandem device allowed us to easily direct the laser catheter tip and deliver the laser energy accurately at the complex plaque burden. In comparison to the previous version of this catheter, the Turbo-Booster®, the set-up time was fast, the device was easier to manage, and the luminal gain exceeded our expectations. Overall, we are very satisfied with the performance of the Turbo-Tandem System."
The Turbo-Tandem was introduced to the US market with two procedures on July 8th and 9th which were presented to the attendees and faculty at the New Cardiovascular Horizons (NCVH) conference in New Orleans. The first case was performed by Professor Scheinert and was televised live via satellite from Leipzig, Germany. The second case, which was the first Turbo-Tandem case in the United States, was performed by Dr. Craig M. Walker, Founder and Medical Director of the Cardiovascular Institute of the South at Houma, LA and was also televised live to the NCVH conference. Dr. Walker treated a 95% discrete proximal lesion in the superficial femoral artery, debulking and atherectomizing the lesion utilizing four quadrant passes followed by circumferential passes. Post-treatment, angiography confirmed a sizable luminal gain, with excellent distal runoff and no evidence of embolic impact. After the procedure, Dr. Walker stated, "I have had extensive experience with the Spectranetics Turbo-Booster® to treat disease in the superficial femoral and politeal arteries, and the Turbo-Tandem is a significant improvement to the original design. It is a lower-profile 7 French system, is very easy to use, and I encountered no slippage of the catheter as I maneuvered it through the stenotic segments of the artery. This is a very useful device for ablating plaque in the large arteries above the knee."
Press release: Spectranetics Announces First Human Uses of Turbo-Tandem(TM) System...
(0)
Thursday, July 16, 2009
New Cerebral Oximeter from Nonin Granted US OK
Nonin Medical has received FDA clearance for the Model 7600 regional oximetry system. Similar to other cerebral oximeters, all of which are designed for operating room use on patients undergoing cardiac, vascular and neurosurgical procedures, as well as on patients in critical care units, the 7600 model provides continuous monitoring of cerebral oxygenation, so clinicians can take steps to prevent brain ischemia in susceptible patients.
More details about the device:
Utilizing next-generation near-infrared spectroscopy (NIRS) — Nonin's proprietary EQUANOX™ regional oximetry (rSO2) technology — the Model 7600 measures oxygen saturation in the cerebral cortex. The innovative sensor design effectively removes surface tissue effects that can influence measurement accuracy — isolating measurements of the cerebral cortex and providing rSO2 values. The Model 7600 offers industry-leading signal processing to enhance efficiency and an intuitive user interface with Bluetooth® wireless connectivity to streamline file access and storage.
Features from the product page:
Proven Accuracy: ARMS of 2.7 along trend lines relative to jugular bulb measurements (SjvO2). Enhanced (rSO2) accuracy designed to eliminate the impact of surface effects (i.e. skin, bone, meninges, etc.) Exceptional Repeatability: ± 2 digits Unmatched Convenience and Efficiency: Quick and easy to set up along with improved operational efficiency by eliminating the need to capture a new baseline when sensors are changed or repositioned Fast Readings: Near-instantaneous baseline measurement Superior Sensor Architecture: Dual light emitters enable consistently accurate measurements — even if one emitter is obscured Easy to Use: Intuitive, large-screen display is simple to read and requires minimal training Highly Versatile: Can be used in numerous clinical environments Rugged Durability: A compact, rugged design specifically built to resist the potential hazards in clinical environments
Press release: Nonin Medical Announces FDA Clearance for its Next-Generation Regional Oximetry System...
Product page: Model 7600 Regional Oximetry System...
(0)
Tuesday, July 7, 2009
NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled
SonoSite announced this morning the release of a new portable ultrasound NanoMaxx system that weighs only 6 pounds. The company claims that this point-of-care ultrasound produces imagery similar in quality to the firm's flagship M-Turbo model. Designed for mobile applications (such as private offices, emergency rooms or EMRs, central line accesses on the floor, etc.), the system sports battery with two hour life. For this model the company offers a comprehensive line of transducers that deliver "high resolution diagnostic imaging across a range of clinical applications to support clinical diagnosis and to guide interventional procedures." Ready to be distributed internationally, the device still needs final approval from the FDA to be marketed in the US.
Features from the announcement:
One Button Technology Optimizes Workflow
Based on SonoSite’s 4th generation Turbo technology platform, the NanoMaxx system incorporates proprietary, advanced imaging algorithm technologies, including ColorHD™ to deliver exceptional image quality in a lightweight, rugged form factor.With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.
Designed to Help Hospitals Meet New Standards of Care
Clinical studies have proven that bedside ultrasound increases the accuracy of interventional procedures and it is now recommended by two government-based agencies1 and three US medical societies.2 At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for hemothorax, hydrothorax and pneumothorax, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.The clinical capabilities of the NanoMaxx will help eliminate the risk and cost of transporting patients to the imaging lab for many examinations and procedures.
Mount it. Carry it. Or Use it on a Stand
The small footprint of the NanoMaxx system, along with its space-saving solutions, enables seamless integration with a variety of exam-room configurations. It can be wall mounted, placed on an exam table, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, the operating room or to a field site for immediate use.Built to Last
The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, allows it to be used in the most austere and demanding environments. A magnesium shell that is significantly stronger and lighter than plastic helps to protect the system against accidental droppage. As with all SonoSite systems, the NanoMaxx ultrasound tool and its transducers are built to withstand a one meter drop test.
Product page: SonoSite NanoMaxx...
(0)
» Smoother GORE VIABAHN Endoprosthesis Gets Approved in US (July 2, 2009)
» Improve Your Ultrasound Skills With New SonoSite iPhone App (June 24, 2009)
» Voice Activated SonoSite Ultrasound System Keeps Hands Free to Perform Procedures (June 19, 2009)
» Cook Launches Z-TRAK PLUS Introduction System for Zenith TX2 TAA (June 12, 2009)
» Emboshield NAV6 Embolic Protection System Released by Abbott (June 12, 2009)
» Option IVC Filter Receives FDA Approval (June 11, 2009)
» ViRob, a Cavities Crawler (May 28, 2009)
» Retrievable SafeFlow IVC Filter Gets FDA Nod for Everything But Retrieval (May 21, 2009)
» Digital Subtraction Angiography on a Single Image (May 14, 2009)
» BrainLab's Digital Lightbox Getting an Upgrade (May 13, 2009)
» Abbott's New PVD Offerings (May 7, 2009)
» Magnus Operating Table from Maquet (May 4, 2009)
» Cook's Drug-eluting Peripheral Stent Performs Well in Large Study (April 17, 2009)
» Cardinal's Endura Scrubs for the Modern Clinician (March 19, 2009)
» Catheter for Calcium Blocked Peripheral Vessels Gets US Green Light (March 6, 2009)
» MRI May Replace X-Rays for Catheterizations (March 3, 2009)
» HYPER-IMS, a Tiny Implantable Wireless Pressure Monitor (January 5, 2009)
» Amimon's High Definition Wireless Video Goes Clinical (January 5, 2009)
» RHEOS Device for Blood Pressure Control Undergoing New Trial (December 22, 2008)
» WAND Vascular Introducer Gets FDA OK (December 10, 2008)
» Zonare Shows Off Proprietary Ultrasound Technology (December 3, 2008)
» TruSystem 7500: New OR Table from TRUMPF (November 21, 2008)
» Talent TripleA Stent, Now with a New Delivery System (November 19, 2008)
» Boston Scientific's Carotid Artery Stent Gets FDA OK (November 7, 2008)
» High Flow Microcatheter from Cook Medical Goes Live (October 30, 2008)
» PlasmaBlade Finds New Uses With New Attachments (October 29, 2008)
» Talent Stent Graft with the New Delivery System Goes on Sale in US (October 23, 2008)
» New Angio-Seal Evolution Goes to Market (October 17, 2008)
» Europe Green Lights Nanofabric-based AVflo Vascular Graft (October 7, 2008)
» LOGIQ E9: The Next Plane in Ultrasonography (September 16, 2008)
» In the Works: A Valve for Chronic Venous Insufficiency (September 16, 2008)
» Stereotaxis Magnetic RF Guidewire Gets FDA OK (September 9, 2008)
» EKOS MicroSonic Accelerated Thrombolysis System (September 9, 2008)
» Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities) (August 19, 2008)
» CX50 Portable Ultrasound from Philips Goes On Sale (August 5, 2008)
» A Trial of Zenith Fenestrated AAA Endovascular Graft Goes On (August 1, 2008)
» V Series Neuro Clot Retrievers from Concentric (July 30, 2008)
» PlasmaBlade System Gets FDA Go Ahead (July 24, 2008)
» Pathway Medical Gets FDA OK for Company's Peripheral Plaque Drill (July 23, 2008)
» Zenith TX2 TAA Endovascular Stent Available in US (July 14, 2008)
» Epocrates Rx Now on iPhone (July 14, 2008)
» Endurant Stent Graft System For Tortuous Aortas (July 10, 2008)
» G-Wire: Visually Positioned Guidewire for Faster, Safer Procedures (June 30, 2008)
» Artificial Mesh for Prevention of Post Operative Abdominal Wall Defects (June 17, 2008)
» Talent Thoracic Stent Graft System Approved in US (June 6, 2008)
» "Conditioned" Tissue-Engineered Blood Vessels Hold Promise (June 4, 2008)
» The Third Install in the US of Aquilion ONE CT from Toshiba (May 21, 2008)
» Demand Is High for Brilliance iCT, a 256-Slice CT from Philips (May 19, 2008)
» CE Mark Given to AMPLATZER Vascular Plug III (May 19, 2008)
» Novel Surgical Biomaterial Receives Regulatory Approvals (May 14, 2008)
» Peak PlasmaBlade Wants to Be The New Bovie (May 7, 2008)
» Gore Receives EU's CE Mark for PRECLUDE Vessel Guard (May 7, 2008)
» VascuSeal Goes on Sale in Europe (May 6, 2008)
» Vasovist, a Vascular MRI Contrast Agent, Meets FDA Requirements (April 25, 2008)
» Angiotech Suspends Vascular Wrap Trial Enrollment (April 23, 2008)
» Medtronic Defender Embolic Protection Filter Approved in EU (April 18, 2008)
» FDA OK's Endovascular Talent Stent for AAAs (April 17, 2008)
» Open Aortic Stapler Approved in EU (April 15, 2008)
» NeuroFlow Cath Promises to Save Ischemic Brains (April 7, 2008)
» Open Aortic Stapler from ES Vascular (March 28, 2008)
» Metricath Gemini Double Balloon Catheter Showing Promise (February 19, 2008)
» z.one ultra System (January 25, 2008)
» ReeTrakt Surgical Retractor (January 15, 2008)
» Endovascular Talent™ for AAAs (December 5, 2007)
» Acuson P50 Portable Ultrasound System from Siemens (November 28, 2007)
» AquilionONE CT from Toshiba Cleared by FDA (November 27, 2007)
» Artis zee from Siemens (November 26, 2007)
» New Surgical Instruments from KLS Martin Group (November 26, 2007)
» FusionOptic™ Technology from Leica (November 16, 2007)
» Non-Contact 3D Med Display (November 7, 2007)
» SonoLysis™ Therapy: Stroke Treatment with Ultrasound (November 5, 2007)
» REVA Bioresorbable Polycarbonate Stent (October 19, 2007)
» Tissue-Engineered Blood Vessels Perform Well in a Study (October 9, 2007)
» Sony's Versatile HD Med Monitor (October 5, 2007)
» M-Turbo™: New Portable Ultrasound from SonoSite (October 2, 2007)
» Peripheral Vascular Solutions from MultiGene Vascular Systems (September 28, 2007)
» Diamond Tipped 200,000 RPM Artery Drill (September 26, 2007)
» CT Vascular Analysis via the Internet (September 4, 2007)
» Celect™ Vena Cava Filter (July 31, 2007)
» ACUSON P10: An Ultrasound System That Fits in a Pocket (June 25, 2007)
» Blood Vessels Grown from Stem Cells (June 19, 2007)
» UniFit™ Abdominal Stent Graft (June 14, 2007)
» ArterioVision™: The CIMT (Carotid Intima-Media Thickness) Test (June 11, 2007)
» Force Sensor for Cerebral Aneurysm Treatment (March 16, 2007)
» Talent™ Thoracic Stent Graft System (March 5, 2007)
» Nanofiber-based Vascular Grafts by Nicast (February 23, 2007)
» SafeFlo® IVC Filter (December 18, 2006)
» Positive Results from Trial of Rheos Baroreflex Hypertension Therapy (November 16, 2006)
» Innova IVUS Installed (October 23, 2006)
» Carotid Stents Represent Serious Clot Risk without Downstream Filter (October 20, 2006)
» Gelling Up Artificial Grafts (October 19, 2006)
» MPH® Hemostatic Technology (October 3, 2006)
» Nanocrystalline, Silver Coated, Long-Term Dialysis Catheters by Spire (September 22, 2006)
» Live Surface, A Software for Surgeons (August 2, 2006)
» Rebuilding Capillary Networks with Stem Cells (July 7, 2006)
» Scan2Knit (April 19, 2006)
» AneuRx® AAAdvantage™ (March 28, 2006)
» Color Me Approved: StarClose Vascular Closure System from Abbott (March 17, 2006)
» ImPressure™ Sensor (March 10, 2006)
» Wireless C-Arms from Xograph (March 3, 2006)
» The BioGlue® (January 25, 2006)
» The EndoSure™ Wireless AAA Pressure Measurement System (November 11, 2005)
» The SilverHawk™ Plaque Excision System (October 26, 2005)
» Abbott's Stent To Treat Patients At Risk Of Stroke (September 19, 2005)
» Gore VIABAHN® Endroprosthesis Stent: Now Approved (September 8, 2005)
» Inflatable Stocking Therapy (August 24, 2005)
» The LONG Arm of Medicine (May 19, 2005)
» DVX Catheter Clot Remover (May 4, 2005)
» Novel Device for High Blood Pressure Implanted (April 1, 2005)
» PDAnet Lab System (March 24, 2005)
» The BioScanIR System (March 23, 2005)
» The Resolution System for Vascular Occlusive Disease (March 16, 2005)
» CryoPlasty therapy: more positive results reported (February 23, 2005)
» The CLiRpath system (January 27, 2005)
» VNUS Closure Procedure (December 29, 2004)
» "Helical Branch Device" (December 29, 2004)
» Signals From Deep Inside (December 28, 2004)
