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...
(0)
Monday, January 5, 2009
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 ...
Globes: Wireless video co Amimon wins deal with Stryker...
(0)
Monday, December 22, 2008
RHEOS Device for Blood Pressure Control Undergoing New Trial
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 ...
Flashbacks: Positive Results from Trial of Rheos Baroreflex Hypertension Therapy ; Novel Device for High Blood Pressure Implanted
(1)
Wednesday, December 10, 2008
WAND Vascular Introducer Gets FDA OK
Access Scientific out of San Diego, California wants to cannulate the central venous access market. The company just won FDA approval for its WAND™ MicroAccess Safety Introducer, a novel device that combines needle, guidewire, and the catheter into one system.
The MicroAccess WAND is the first of several planned WAND devices from Access Scientific to receive FDA clearance. The devices combine all components of the older, Modified Seldinger Technique into a unitary device that provides faster, safer, simpler over-wire vascular access.The MicroAccess WAND is expected to be used primarily in interventional radiology suites and cardiac catheterization labs. Subsequent iterations -- including the PICC WAND(TM) and Power WAND(TM) now in development - are designed to be used primarily by vascular nurse specialists for insertion of peripherally inserted central catheters (PICCs) and extended-dwell peripheral IVs.
The Seldinger technique was developed in 1953 to reduce complications associated with the introduction of catheters and other medical devices into blood vessels and hollow organs. Because there have been few significant improvements to the technique since it was invented, what is now known as the Modified Seldinger Technique (MST) still carries serious risks for patients and clinicians.
Among the patient risks of MST that are reduced by the Accelerated Seldinger Technique is air embolism. Beginning in October 2008, the Centers for Medicare & Medicaid Services (CMS) ceased reimbursing healthcare institutions for air embolism, which CMS considers preventable.
In addition to uniting the elements needed to perform the Seldinger technique into one unitary device, The WAND is designed to reduce the risk of accidental needlesticks, bleeding, contamination, guidewire embolism, and loss of cannulation. Its "Fast-flash" feature provides early detection of vessel entry.
Learn more by going to the product page: MicroAccess WAND ...
Press release: Access Scientific Receives FDA Clearance for The WAND ...
(0)
Wednesday, December 3, 2008
Zonare Shows Off Proprietary Ultrasound Technology
At the RSNA 2008 conference this week, ZONARE Medical Systems out of Mountain View, California is showing off its latest ultrasound transducers and image processing software for improved image quality. The company describes its z.one ultrasound system as "smaller, lighter, more maneuverable, and nimbler than any system of equivalent image quality."
From the press release:
New Transducer Technology The C4-1 is a small footprint, curved array transducer designed by ZONARE's acoustic engineers. It offers physicians improved access and imaging performance resulting in improved penetration with sensitive Doppler imaging. All ZONARE customers worldwide have access to this new technology on their current z.one ultrasound platform.ZONARE is also showing its new L14-5w high resolution, high frequency transducer, which offers broad bandwidth for improved imaging of small parts, breasts and superficial anatomy. Its wide field of view has an aperture of 55mm offering virtual apex capability, and it has 10 frequencies including three fundamental, one tissue harmonic, two compound imaging and two each for color Doppler and PW Doppler modes.
Elastography and 3D Imaging
The z.one ultrasound system will feature new elastography applications that enable qualitative visual assessment of the mechanical stiffness properties of tissue. The high resolution elastography images are generated and visualized using a variety of grayscale and colorized maps and the L10-5 and L14-5w transducers are supported. Clinicians using the new applications report that this technique may provide significant new diagnostic information.
The comprehensive 3D ultrasound imaging capabilities are available for the z.one ultra system with primary applications for obstetrical imaging during the second and third trimester. The new C8-33D curved linear transducer offers mechanical sweep array, 3D fetal surface rendering, 3D Multi Planar rendering and additional diagnostic tools. The new 3D imaging capabilities are also available for general abdominal ultrasound imaging. ZONARE's 3D ultrasound imaging expands the clinical utility of the z.one ultra system and may reduce exam time, enabling physicians to spend additional time on patient care.Proprietary Software
The difficult-to-image patient population makes up a large percentage of patients examined with ultrasound today and includes people who are overweight, elderly, muscular, or who have a thick body wall. Traditionally, a definitive ultrasound diagnosis for this patient group was challenging and often these patients were referred for more expensive testing. ZONARE has engineered new proprietary software for ZONE Sonography technology and, when combined with the company's new C4-1 transducer, clinicians have a new tool to image their most technically difficult patients with advanced image clarity.
Press release: ZONARE Medical Systems Introduces Advancements for z.one Ultrasound Platform at RSNA ...
Product page: z.one Ultrasound Platform ...
(0)
Friday, November 21, 2008
TruSystem 7500: New OR Table from TRUMPF
Thanks to its modular design, this new OR table from TRUMPF can accommodate almost all known surgical positions, and can provide an optimal operating environment for all kinds of cases, from hip pinnings to robotic prostatectomies.
In surgery, no operation is identical to another. So it's not just surgeons and staff who need to be flexible – that requirement applies to OR tables as well. For the TruSystem 7500 OR table system, TRUMPF offers universal OR tabletops with a variety of application options, and special OR tabletops for specific requirements. Depending on the desired application and budget, from an extensive product line users can put together the precise OR table that fits their individual needs.TruSystem 7500 is consistently designed to simplify the everyday clinical work of physicians and staff, and to support them in their daily tasks. OR tabletops with up to three motorised joint pairs make it possible to use remote controls to position the patient quickly, safety and precisely. Manual adjustments to the tabletop are reduced. Staff can program the adjustment speed of all tabletop motors as needed. To return to the zero position, all motors in the tabletop work simultaneously, saving time.
A novel feature is the third motorised joint pair between the lower and upper back plates, which enables new positioning options. For thoracic surgeries, for instance, the patient's ribcage can be stretched precisely to the desired degree by pushing a button, so it can be opened more easily. Complicated positions, such as the side thorax position, can be assumed quickly, precisely and conveniently for both patient and staff. The patient also benefits from ergonomic, safe positioning, since the lengths of the individual tabletop segments correspond to the average distances between joints in the human anatomy.
TruSystem 7500 has universal coupling points, which have proven their worth in other TRUMPF OR tables. This latest OR table system is thus compatible with the entire TRUMPF accessory line, as well as with all other TRUMPF OR tables. The mechanically encoded coupling points prevent disallowed configurations of the table. Thus new and existing customers can quickly familiarise themselves with operation of the table. Moreover, they benefit from the option of combined use with predecessor models, and thus from the safety of investment in TRUMPF products. This philosophy permeates the entire TRUMPF medical technology portfolio.
One special feature of the “ST 26” special OR tabletop: First, the Trendelenburg capability is split between the column and the top. Besides the 45 degrees offered by the column, the tabletop can be adjusted by another 20 degrees. With the TruSystem 7500, therefore, an extremely low head or foot position of 65 degrees can be achieved. If the user doesn't need this additional functionality, less expensive universal OR tabletops can be selected.Special TRUMPF positioning accessories can be mounted on the TruSystem 7500 tabletops at any time. A spinal column positioning assembly, an extension unit or carbon elements for intraoperative X-ray diagnosis, for instance, make this jack-of-all-trades a specialist in just moments.
Check out all the available positions and accessories in this product brochure...
Product page: TruSystem 7500...
(2)
Wednesday, November 19, 2008
Talent TripleA Stent, Now with a New Delivery System
Medtronic has announced today the U.S. launch of the company's Talent Abdominal Stent Graft, a slick new endovascular device, where "slick" means hydrophilic, thanks to an innovative Xcelerant Hydro Delivery System, a specially coated deployment device that is supposed to make endovascular AAA repairs a bit easier . This is not an unexpected news, as it is essentially a replay of Medtronic's recent launch of the similar system for thoracic aortic aneurysms.
The Xcelerant Hydro Delivery System features a hydrophilic coating which attracts and holds water at the device surface to reduce friction. The coating is designed to aid navigation through the femoral and iliac arteries en route to the aorta.“The combination of the Xcelerant Hydro Delivery System and the Talent Abdominal Stent Graft represents another major step forward for the treatment of patients with abdominal aortic aneurysms,” said Dr. Manish Mehta of Albany Medical College and Albany Medical Center Hospital in New York. “The hydrophilic coating takes deliverability to a new level and gives endovascular interventionalists like me greater control over the deployment of this excellent stent graft, which has no equal in terms of sizes and profile. Taken together, these technologies simplify the procedure and enhance patient care – a powerful combination indeed.”
“The Xcelerant Hydro Delivery System again demonstrates Medtronic’s innovation in the field of EVAR,” said Tony Semedo, vice president and general manager of Endovascular Innovations at Medtronic. “The launch of the Talent stent grafts earlier this year made EVAR available to significantly more patients than possible with earlier technologies. Now, by introducing the Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System in the United States, we have enhanced navigation. All of these innovations benefit physicians and patients alike.”
Medtronic Launches New Medical Device in U.S. to Improve Treatment of Aortic Aneurysms...
Flashbacks: Talent Stent Graft with the New Delivery System Goes on Sale in US; Talent Thoracic Stent Graft System Approved in US ; FDA OK's Endovascular Talent Stent for AAAs; Talent Thoracic Stent Graft System; Talent Thoracic Stent Graft System
(0)
Friday, November 7, 2008
Boston Scientific's Carotid Artery Stent Gets FDA OK
The popular carotid stent, WALLSTENT® Monorail® Endoprosthesis, from Boston Scientific has been approved for marketing by US regulators. The device, indicated for the treatment of patients with carotid artery disease who are at high risk for surgery, has been on the European market for a few years now. According to its press release, the company plans to launch the product immediately in the United States.
The Carotid WALLSTENT is a self-expanding stent mounted on a rapid exchange delivery system, designed to re-open the carotid artery by treating stenoses, and improve blood flow to the brain. The stent features a closed-cell design, engineered for excellent lesion coverage and angiographic results. The system is designed to be highly deliverable and provide access to the toughest lesions.It is used in conjunction with the FilterWire EZ™ Embolic Protection System, which is designed to capture plaque debris released during the stenting procedure, preventing it from traveling to the brain, where it could create an increased risk for stroke. The device features simplified filter sizing - accommodating vessel diameters between 3.5 mm and 5.5 mm - and offers efficient preparation, deployment and retrieval.
"The closed-cell design of the Carotid WALLSTENT Endoprosthesis is intended to provide increased scaffolding for optimal lesion coverage and a smooth inner lumen," said Barry T. Katzen, M.D., Medical Director, Baptist Cardiac and Vascular Institute, Miami. "This feature will make the Carotid WALLSTENT an attractive new treatment option for U.S. physicians and their patients."
The Carotid WALLSTENT Endoprosthesis with the FilterWire EZ System is the only carotid artery stent system approved in the United States with an indication that includes the treatment of bilateral carotid artery disease (blockages in the carotid arteries on both sides of the neck).
Product page: WALLSTENT® Monorail® Endoprosthesis...
Press release: FDA Approves Boston Scientific's Carotid Artery Stent...
(0)
Thursday, October 30, 2008
High Flow Microcatheter from Cook Medical Goes Live
Cook Medical won FDA approval for the firm's MiraFlex™ High Flow catheter, which is indicated "for use in small vessel or superselective anatomy for diagnostic and interventional procedures," according to the company.
From the press release:
With a generous .025 inch inner diameter, MiraFlex High Flow enables optimal coil delivery and can be used in combination with a wide variety of embolisation materials, including the top-selling MicroNester® and Tornado® Microcoils™ from Cook. A kink-resistant braided construction along the entire length of the catheter shaft to the radiopaque band provides improved torque response and traceability for quicker vessel selection, while maintaining optimal catheter visualisation. The braided design also contributes to the flexibility and durability of the catheter, which carries a rated burst pressure of 1000 psi and achieves the higher flow rates clinicians depend upon.Each MiraFlex High Flow microcatheter has a hydrophilic coating designed to greatly reduce surface friction, and is engineered with five durometer zones ranging from a stout proximal portion that delivers improved pushability and control, to a soft, flexible distal tip that reduces the risk of vessel trauma.
Press release: Cook Medical Receives CE Mark Approval for MiraFlex™ High Flow Microcatheter
Product brochure: MiraFlex Microcatheter
(0)
Wednesday, October 29, 2008
PlasmaBlade Finds New Uses With New Attachments
PEAK Surgical, maker of the innovative PlasmaBlade replacement of the bovie, has put a couple extensions for its device onto the market.
The PlasmaBlade Needle, which has a fine needlepoint tip, is specifically designed for ultra-precise surgical procedures. The PlasmaBlade EXT is designed for use in surgical procedures requiring an extended-reach tip.In July, the U.S. Food and Drug Administration granted PEAK Surgical 510(k) clearance to market the PEAK® Surgery System, including the PlasmaBlade 4.0, for use in general surgery. The PlasmaBlade 4.0 is designed to be used to cut through all types of soft tissue, including skin, fat and muscle. All of the PlasmaBlade tissue dissection tools are used in conjunction with PEAK's PULSAR™Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to create surgical incisions and control bleeding. They offer the exacting control of a scalpel and the coagulation of traditional electrosurgery without extensive collateral damage.
Press release: PEAK Surgical Introduces PlasmaBladeTM Product Line Extensions for Use in General Surgery
Flashbacks: PlasmaBlade System Gets FDA Go Ahead; Peak PlasmaBlade Wants to Be The New Bovie
(0)
Thursday, October 23, 2008
Talent Stent Graft with the New Delivery System Goes on Sale in US
Medtronic is launching its Talent™ thoracic stent graft in the United States that features the new Xcelerant system for placement of the device.
Recently approved by the FDA, the Talent Thoracic Stent Graft with the Xcelerant Delivery System is now available to physicians across the United States and expands the applicability of thoracic aortic repair (TEVAR) to more patients with thoracic aortic aneurysms.The unique features of the Xcelerant Delivery System and the Talent Thoracic Stent Graft provide meaningful benefits to both physician and patient: a wide range of sizes so more patients can be treated; improved trackability and controlled deployment for easier and more accurate stent graft placement; and high radial force as shown in competitive bench testing.
Press release: Medtronic Launches New Medical Device that Improves Minimally-Invasive Treatment of Thoracic Aortic Aneurysms
Product page: Talent Thoracic Stent Graft...;
Flashbacks: Talent Thoracic Stent Graft System Approved in US ; FDA OK's Endovascular Talent Stent for AAAs; Talent Thoracic Stent Graft System; Talent Thoracic Stent Graft System
(0)
Friday, October 17, 2008
New Angio-Seal Evolution Goes to Market
St. Jude Medical is announcing American and European regulatory approvals of the Angio-Seal™ Evolution Vascular Closure Device, a product that, as the company promises, will make the life of cardiologists, radiologists, vascular surgeons, and others who go endovascular, easier. In addition to instant hemostasis, the device allows vascular closure with one handed operation, promises decreased number of complications, earlier ambulation, and even higher patient satisfaction. And you thought that patients could care less about their femoral region!
From the press release:
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.The Angio-Seal Evolution platform features an entirely new delivery system that significantly reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). With Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site. The new device's automated collagen compaction system ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.
Press release: St. Jude Medical Announces U.S. and European Approval of Angio-Seal Evolution Vascular Closure Device
Product page: Angio-Seal™ Evolution™
Flashback: Angio-Seal: A VIP in Cardiac Cath
(0)
Tuesday, October 7, 2008
Europe Green Lights Nanofabric-based AVflo Vascular Graft
There is a new player in the AV fistula market. Nicast, a company out of Lod, Israel that specializes in the technique of electrospinning to create non-woven fabrics out of microfibers, has received the EU CE Mark of approval for the firms's AVflo™ artificial vascular graft. The best part about the material composing the graft is in its ability to automatically close the puncture hole once the dialysis needle has been removed.
From the press release:
The AVflo is the first vascular access graft to apply the many beneficial properties of electrospun nanofabric. Its self-sealing, non-woven, synthetic fiber structure provides excellent primary and secondary patency (unobstructed blood flow); allows for dialysis within 24-48 hours after implantation; and self-seals within less than five minutes following the withdrawal of the dialysis needles. It is simple to implant and to suture to blood vessels; the needle punctures and suture holes do not bleed. AVflo is strong enough to withstand the pressure of blood flow, yet thin enough for blood flow to be easily felt through it.
From the product page:
excellent primary and secondary patency (unobstructed blood flow)
early access, enabling dialysis within 24-48 hours after implantation
rapid arterial and venous puncture sealing (less than 5 minutes) following dialysis needle withdrawal
rapid sealing (less than 5 minutes) of suture perforations and halting of blood weeping
easy suturing of graft to blood vessels
easy implantation; no end-to-end twisting of graft during implantation
easily palpable thrill (blood flow vibration)
Press release: Nicast's AVflo(TM) for Hemodialysis Patients Receives CE Mark
Product page: AVflo™ Vascular Access Graft
Nicast technology page: Electrospinning
Flashback: Nanofiber-based Vascular Grafts by Nicast
(0)
Tuesday, September 16, 2008
LOGIQ E9: The Next Plane in Ultrasonography
GE Healthcare has just introduced a new ultrasound system, LOGIQ® E9, designed "for radiology and vascular applications," in other words, a general ultrasound system. The beauty of LOGIQ® E9 is in its new image technology and real-time capability to merge an ongoing ultrasound exam with previously acquired CT, MR or ultrasound images.
The new LOGIQ® E9 includes Volume Navigation, an innovative tool which incorporates two key components to maximize the system’s new agile ultrasound architecture: ‘Fusion’ to combine the advantages of real-time ultrasound imaging with the high spatial and contrast resolution of CT, MR or PET; and a ‘GPS-like technology’ to track and mark a patient’s anatomy during the ultrasound exam, bringing confidence and productivity to both diagnostic and interventional studies.“GE’s new LOGIQ E9 helps address the biggest challenge in ultrasound radiology and vascular care – how to leverage clinical images from previous diagnostic imaging studies for interventional or diagnostic ultrasound procedures,” said Terri Bresenham, GE’s Vice President of Diagnostic Ultrasound and Information Technology. “We worked closely with a global team of radiologists and sonographers to develop this new ultrasound architecture, giving clinicians the advantages of imaging modalities - MR, CT and PET – and it is already reigniting the imagination of the ultrasound industry.”
This new GE architecture, called Agile Ultrasound, replaces old assumptions of conventional ultrasound systems with new, modular mathematical models that provide more accurate measurements of how sound interacts with different body tissue types. The result of the LOGIQ E9 architecture is an improved, more life-like image without a lot of manual adjustments to view specific anatomy.
Another key feature for the LOGIE E9 is Scan Assistant, which aids clinicians to put the emphasis on diagnosis rather than on keystrokes. This tool allows a clinician to pre-program the actions most often performed, and then let the system do the detailed manipulations as the patient is scanned. It improves exam time up to 54 percent, automatically inserts comments, completes measurements, steers Color Doppler, sets up imaging controls and modes, and improves ergonomics.
“GE Healthcare’s broader ultrasound objective is to bring quality images, better workflow, and innovative tools to clinicians,” said Bresenham. “This LOGIQ E9 system is an entirely innovative for a groundbreaking new generation of ultrasound systems.”
Check out the new product brochure, released for the American audience:
Product page: LOGIQ E9...
Press release: GE HEALTHCARE INTRODUCES ULTRASOUND FUSION; NEW LOGIQ E9 MERGES REAL-TIME ULTRASOUND WITH CT, MR, AND PET...
(0)
In the Works: A Valve for Chronic Venous Insufficiency
Engineers at the Georgia Institute of Technology are poised to deliver an innovative new valve, designed to function as a back flow prevention device for patients suffering from chronic venous insufficiency. Whether such a system translates into clinical benefit is, of course, a million dollar question.
“Blood flows to the toes because of gravity, but the body uses vein valves to pump blood in one direction back to the heart,” said David Ku, the Lawrence P. Huang Endowed Chair in Engineering and Entrepreneurship and Regents’ Professor in the George W. Woodruff School of Mechanical Engineering at Georgia Tech. “However, sometimes a vein valve dissolves away after a blood clot. The loss of the valve leaflets allows blood to flow the wrong way, causing swelling in the legs and ankles.”Ku is leading a research team that has developed a prosthetic vein valve to replace damaged, non-functioning valves. The prosthetic vein valve design and results from laboratory studies were presented at the Society for Biomaterials Fall Symposium in Atlanta on September 12. The research – under way for the past five years – is funded by the Wallace H. Coulter Foundation and the National Collegiate Inventors and Innovators Alliance...
Ku and his collaborators believe the valve they have developed will overcome previous difficulties. The one-way flap is made of poly(vinyl alcohol) cryogel, a material patented by Georgia Tech in 1999. The material has many useful attributes, including its biocompatibility with body tissue because of its attraction to water; the ability to adjust its mechanical strength; flexibility comparable to that of natural body tissue; and composition of organic polymer, rather than silicone.
The researchers will begin conducting preclinical animal trials at Emory University in October to test the in vivo biocompatibility and performance of the prosthetic vein valve prototype in sheep. Sheep were chosen because their cardiovascular geometry and physiology are similar to those of humans.
In each animal trial, two prosthetic vein valves will be implanted by Milner. [Dr. Ross Milner is an assistant professor of surgery at Emory University.] The researchers will test the biocompatibility and performance of the devices for four weeks, using imaging techniques to check that the valves remain in the proper location, are open and allow blood to pass through the vein.
The animal trials will be conducted after several years of optimizing the valve design and testing it in the laboratory. When the Georgia Tech researchers started designing the valve, they wanted it to be as similar as possible to normal, anatomic venous valves. They focused on two major design criteria: the valve had to withstand high pressures without leaking and the valve had to open with small pressure gradients, even after 500,000 cycles of opening and closing, which is equivalent to a half year...Sathe conducted the initial laboratory tests and found that the valve met the mechanical design criteria – it could withstand pressures of more than 500 millimeters of mercury and opened with a pressure gradient of 2.6 millimeters of mercury, which matched physiologic vein valve function. Detailed laboratory testing procedures and results were described in the June 2007 issue of the Journal of Medical Devices.
Next, Farrell developed a laboratory method to test whether blood clots would form inside the prosthetic valve. Results showed that the new generation of valves remained open with no clot formation after 120 minutes of blood flow, whereas control valves lined with polyester closed up after approximately six minutes of perfusion and showed blood cells adhering to the valves.
The laboratory tests showed that the prosthetic vein valve exhibited low flow resistance, strong competency, fatigue-resistance, low clot formation probability and material flexibility, which allowed the researchers to move forward to the animal studies.
The next step after conducting the animal studies will be human clinical trials.
Press release: Prosthetic Vein Valve Designed to Improve Venous Blood Flow...
(0)
Tuesday, September 9, 2008
Stereotaxis Magnetic RF Guidewire Gets FDA OK
The FDA has given Stereotaxis a green light to market the company's magnetically steered PowerAssert RF guidewire for peripheral chronic total occlusions. We have covered Stereotaxis and its NIOBE II remote magnetic system on many occasions before, as our flashbacks at the end of this post testify. 
We have spoken with a rep for the company who tells us that now, in addition to the previous efforts of Stereotaxis to concentrate on intracardiac procedures, the company will pursue new indications to implement its external magnetic navigation system for peripheral vascular problems.
From a press release by Stereotaxis:
"The major differentiation is that we can steer, in vivo, the wire in the center of the lumen," said Rick Green of Stereotaxis. "As you know there are a few other companies that use laser or debulking to make path. Stereotaxis crosses the lesion with RF, but with does so with precision and accuracy because of our ability to control the distal tip of the device. No other company controls the tip of the device, which we do through computer control guiding the magnetic technology.""Traditional, manual guidewires used for CTO crossing have little or no steering ability and therefore can only be used with great difficulty in tortuous vasculature, requiring a high level of operator skill and carrying a risk of vessel perforation," said Bevil J. Hogg, CEO of Stereotaxis. "Just as the safety, accuracy and efficacy of our Niobe Magnetic Navigation System have contributed significantly to the treatment of patients with cardiac arrhythmias in the field of electrophysiology, we believe that our PowerAssert RF guidewire will improve the prospects for treating patients with peripheral arterial disease.
Press release: FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral Chronic Total Occlusions...
Flashbacks: Philips and Stereotaxis: Joystick Precision for Complicated Caths ; Stereotaxis Zaps Atrial Fibrillation All Right; Stereotaxis
(0)
EKOS MicroSonic Accelerated Thrombolysis System
Responding to a recently released American College of Chest Physicians evidence-based clinical practice guidelines for antithrombotic and thrombolytic therapy (.pdf), EKOS® Corporation from Bothell, WA decided to tout in a press release the company's device, EKOS MicroSonic™ Accelerated Thrombolysis (MSAT) system. MSAT is designed for endovascular dissolution of arterial occlusions and DVT thrombi via the company's proprietary targeted drug delivery catheters that also emit ultrasound energy. EKOS's device has been FDA-cleared for controlled and selective infusion of meds, including thrombolytic, into the peripheral vasculature. It is currently used to treat patients with peripheral arterial occlusions (PAO) and DVTs, but not ones who have pulmonary embolism.
The company explains its technology:
EKOS® has developed a proprietary catheter-based drug delivery system that combines the use of targeted drug delivery catheters and the therapeutic benefits of a high frequency low power microsonic energy.Without microsonic energy, the fabric of a blood clot, called fibrin, is tightly bound (figure 1). The microsonic energy helps temporarily loosen and separate the fibrin (figure 2) for more blood clot permeability. Loosened fibrins increases the availability of more plasminogen activation receptor sites (figure 3). At the same time, the microsonic energy helps drive the thrombolytic agents deep into the blood clot to accelerate the thrombolysis, and ultimately dissolve the clot.
Dual action of the EKOS® microsonic energy enhanced delivery systems provides the following advantages:
Microsonic energy thins the fibrins making the thrombus more permeable to the thrombolytic drug.
Drives thrombolytic drugs into the loosened clot.
No reported fragmentated emboli often associated with more aggressive mechanical techniques.
No reported hemolysis, a complication often associated with mechanical devices.
Reduces fluoroscopy time.
Minimizes need for attention from hospital staff because the system self regulates and optimizes the power of the microsonic energy delivered. In Laboratory in vitro testing, the EkoSonic system dissolved thrombus twice as fast as earlier EKOS systems - and four times faster than conventional catheter - directed thrombolysis. With no evidence of thrombus breakage. And no hemolysis.
The EkoSonic™ Endovascular System is intended for the controlled and selective infusion of physician – specified fluids including thrombolytics, into the peripheral vasculature.
Press release: Chest Surgeons Suggest Early Intervention For Treatment Of Acute Deep Venous Thrombosis...