Wednesday, May 7, 2008
Boston Scientific ALTREA Pacemaker EU Approved
Boston Scientific just received approval from the EU to market the company's newest family of pacemakers.
The following features are listed in the press release:
ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced therapies while maintaining its small size and battery longevity. It is the first Boston Scientific-branded pacemaker to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen.Multiple Atrial Ventricular (AV) Delay programming options: These options are designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats, a key distinction from other competitive RV pacing algorithms. The ALTRUA 50 and 60 series also include an enhanced AV search hysteresis feature, now with an extendable AV delay out to 400 milliseconds, providing physicians with additional flexibility to tailor device programming for unique patient needs. Minute Ventilation (MV) Blended Sensor: This proprietary technology treats a condition called Chronotropic Incompetence, which is the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress. Boston Scientific's MV Blended sensor is the only sensor that has been shown to restore Chronotropic Competence. Ventricular Rate Regulation (VRR): This feature helps physicians manage patients with frequent atrial arrythmias. Automatic Capture: This capability is designed to offer automatic, safe and accurate ventricular pulse management. The device checks every heart beat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered.
News release: Boston Scientific Announces European Approval and Market Launch of New Family of Advanced Pacemakers
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Wednesday, May 7, 2008
Peak PlasmaBlade Wants to Be The New Bovie
PEAK Surgical, Inc. from Palo Alto, CA hates the bovie cutter/coagulator. The company cannot stand the 1920's technology behind the bovie, and how its thermal function destroys healthy patient tissue around the cut. What do we hate about the bovie? Well, you know: all those bovie induced burns and destroyed gloves that surgeons are regularly subjected to.
Long story short, PEAK Surgical wants its Peak PlasmaBlade, a cold cutter and coagulator, to be the bovie of the 21st century. The company is quite hopeful: a new study presented in a poster session at the ongoing American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans showed that PEAK PlasmaBlade™ "cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery."
More about the technology:
Electrosurgery was invented in the beginning of the 20th century and became one of the most-often used surgical tools after William Bovie introduced his electrosurgery (radiofrequency) generator in 1926. Since then, electrosurgical cutting has been performed using continuous radiofrequency waveforms, which thermally vaporizes soft tissue via an electrical arc through air and Joule heating. This results in a cutting and coagulation action that leaves a wide zone of collateral thermal damage.By contrast, PEAK Surgical’s PULSAR Generator supplies pulsed waveforms that produce short plasma-mediated, highly controlled electrical discharges through extensively insulated electrodes on a handheld device -- the PEAK PlasmaBlade. Because the radiofrequency is provided in short pulses with low duty cycle (fraction of time the voltage is ON), and the PEAK PlasmaBlade is so highly insulated, heat diffusion and associated thermal damage to surrounding tissues is limited, resulting in greatly reduced collateral damage and extreme cutting precision.
PEAK Surgical’s technology including the pulsed plasma-mediated discharges and electrode insulation techniques were originally developed by Professor Daniel Palanker’s group at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. They have been evaluated in ophthalmic applications, including human studies in retinal and cataract surgery – one of the most delicate, precise and difficult types of surgery, and in preclinical studies.
Check out the following product brochure distributed by PEAK Surgical:
Product page: Peak PlasmaBlade...
Press release: PEAK Surgical Announces Positive Results from Preclinical Study of PEAK PlasmaBlade™ for Obstetric and Gynecologic Surgery
Video demonstrating the device...
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Tuesday, April 22, 2008
FDA Approves Thoratec Heart Pump
The FDA has approved Thoratec Corporation's PMA for the HeartMate II Left Ventricular Assist System (LVAS). PMA's are hard to get cleared and implantable blood pumping devices are notoriously difficult to successfully engineer, so you can bet the folks in Pleasanton, CA are in high spirits these days. Some highlights from the press release...
The approval follows a successful clinical trial involving more than 450 BTT patients, including those enrolled under Continued Access Protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.The median duration of support was 132 days, and the cumulative patient support in the trial was 109 years.
Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.
Eighty four percent of the patients survived to hospital discharge or transplantation.
Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status.
The incidence of major adverse events with comparable definitions -- including infections, strokes and bleeding requiring surgery -- was significantly lower than what was clinically observed in the previous BTT study of the HeartMate VE LVAS.
"With this BTT approval, we will now initiate our sales and marketing programs designed to place the HeartMate II in transplant centers that did not participate in the clinical trial. Our hope is to add about 40 new centers during the balance of the year, which would bring the total number of centers implanting the HeartMate II to approximately 80 centers.
More from Thoratec...
Product page: HeartMate II Left Ventricular Assist System...
UPDATE: Statement from the FDA: FDA Approves First Compact Heart Assist Device...
Flashbacks: HeartMate® II Left Ventricular Assist System; Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?; HeartMate II Shown Effective In Waiting Transplant Candidates
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Friday, April 18, 2008
Edwards Trials Company's Minimally-Invasive Pulmonic Valve
Since the pulmonic valve is a semilunar valve just like an aortic one, the technologies designed for one could potentially be used for the other. The case in point is the Edwards' Sapien Transcatheter Valve, reported by us recently, when it was experimentally implanted into human subjects to fix diseased aortic valves. Now the company is testing its promising minimally invasive technology, via transfemoral approach (with the RetroFlex delivery system), for pulmonic position in patients with congenital right ventricular outflow tract problems.
In this transcatheter valve replacement procedure, the Edwards SAPIEN bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a "beating heart" procedure, without requiring cardiopulmonary bypass or an open-chest incision.
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today," said Ziyad M. Hijazi, M.D., M.P.H., director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of pediatric cardiology and professor in the departments of pediatrics and internal medicine at Rush University, Chicago, and a paid consultant to Edwards Lifesciences. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves. This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a failing pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities."
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.
Press release: Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve
Product page: Edwards SAPIEN Transcatheter Heart Valve......
Flashback: Edwards Sapien Transcatheter Aortic Valve Makes Human Debut
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Monday, April 14, 2008
HEARTSTRING III Proximal Seal System for CABG
MAQUET Cardiovascular is releasing the newest model of the popular proximal anastomotic device for heart surgery, designed to offer a complete hemostatic seal without the need for an aortic side clamp. For those of you who are confused, HEARTSTRING now belongs to MAQUET Cardiovascular, after the firm acquired Boston Scientific's Vascular Surgery and Cardiac Surgery divisions, which in turn included the products and services of Guidant Cardiac Surgery.
This latest version of MAQUET's innovative HEARTSTRING proximal seal technology allows surgeons to perform coronary artery bypass grafts without the use of a partial occlusion clamp during beating heart surgery."We firmly believe that off-pump beating heart surgery results in better patient outcomes. The HEARTSTRING device provides a means to reduce aortic manipulation, a well-appreciated risk factor for adverse neurologic complications in coronary artery bypass," said John D. Puskas M.D., Chief of Cardiac Surgery at Emory Crawford Long Hospital and Professor of Surgery. "With its unique features and improved delivery system, the new HEARTSTRING III system makes it easier for the cardiac surgeon to perform a clampless proximal anastomosis for either saphenous vein or radial artery conduits."
The HEARTSTRING III system features an improved seal loader and delivery device for fast, easy placement. Once deployed, it maintains a low compliant profile for optimal hemostasis at the anastomotic site. The HEARTSTRING III system enables surgeons to use their own hand-suturing technique for creating a proximal anastomosis with either venous or arterial grafts. With its elegant design and small operational footprint, there is no foreign material left inside the vessel after completion of the anastomosis. The Aortic Cutter makes a single, clean hole in the aorta for graft placement. The HEARTSTRING III system allows for maximum surgical flexibility. Surgeons have the option to perform distal or proximal grafts first and to use grafts of varying lengths, hooded grafts, and angled take-offs.
Video showing the functionality of the system. (Windows Media)
Product page: HEARTSTRING® III Proximal Seal System
Press release: MAQUET Cardiovascular Launches HEARTSTRING III Proximal Seal System for Coronary Artery Bypass Graft Surgery
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Tuesday, April 8, 2008
Improved Atrial Fibrillation Ablation Technique
Any cardiac surgeons out there? We know many of you may have been wondering if the typical Cox-maze procedure could be improved upon, and today's your lucky day.
A team from the Washington University School of Medicine has shown that changing the typical pattern of lesions in the Cox-maze procedure into a box formation improves outcomes in a whole bunch of boring statistical ways:
From the abstract in the Journal of Thoracic and Cardiac Surgery:
The incidence of early atrial tachyarrhythmia was significantly higher in the single connecting lesion group compared with that in the box lesion group (71% vs 37%, P < .001). The overall freedom from atrial fibrillation recurrence was significantly higher in the box lesion group at 1 (87% vs 69%, P = .015) and 3 (96% vs 85%, P = .028) months. The use of antiarrhythmic drugs was significantly lower in the box lesion group at 3 (35% vs 58%, P = .018) and 6 (15% vs 44%, P = .002) months.
We notice one glaring omission. The authors refer to creating a "box" lesion in the "Cox-maze" procedure...but nowhere do they attempt to introduce the term "Cox-Box".
More from the Washington University School of Medicine
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Friday, March 28, 2008
Abiomed AB5000 Portable Circulatory Support Console Approved in Europe
Abiomed just received EU's CE Mark to market company's new portable VAD power source, developed to allow patients with AB5000 VAD (ventricular assist device) to be able to leave the hospital. The good old standard console is shown in the picture below.
Abiomed's AB5000 Portable Driver, at only 18 pounds, is the lightest and most powerful bi-ventricular system in the industry. It delivers the pressures and vacuums equivalent to Abiomed's AB5000 console and its recently approved iPulse combination console. Internal testing of the Portable Driver and the AB5000 Ventricle has demonstrated high reliability. This testing showed that the Portable Driver is capable of providing full support for a year's intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation, which is estimated to be three times longer than existing portable consoles that weigh twice as much or more. Abiomed's Portable Driver was designed with the latest smart battery technology for extended power capability and the quiet operation of the Portable Driver provides for minimal disruption of the patient's quality of life at-home. Abiomed recently announced FDA labeling approval of one year bench reliability for its AB5000 VAD, which is expected to complement the Portable Driver reliability.
Press release: Abiomed Receives European CE Mark Approval for AB5000(R) Portable Circulatory Support Driver
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Thursday, March 20, 2008
Ornim Oxygen Saturation System FDA Approved
Ornim Medical, out of Lod, Israel, just received FDA approval for its non-invasive cerebral oxygen monitor for use during surgeries. Back in January, we've profiled OrNim's Targeted Oximetry as a potential diagnostic modality not just for the brain, but for monitoring oxygenation of other organs, such as viscera or extremities.
From Globes Online:
OrNim's Ultrasound Tagged Light technology - UTLight, transmits a beam of light through tissue to measure the absorption of light by oxygenated and deoxygenated hemoglobin. The system tags the light with ultrasound beams enabling to bypass superficial tissue, and measure absolute oxygen saturation levels within the monitored tissue.Shechter explains, "If the blood in the area marked by the ultrasound is red and oxygen-rich, it absorbs more tagged light. If the area is light and oxygen-poor, more tagged light is reflected back to us. In this way, we can precisely measure oxygen levels."
More at Globes...
FDA press release: Ornim receives FDA 510(K) clearance (.pdf)...
Flashback: OrNim's Targeted Oximetry
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Monday, March 17, 2008
Impella Percutaneous VAD to be Studied for Acute MI Patients
The FDA today gave approval to Abiomed to proceed with a clinical study of the Impella® 2.5 Circulatory Support System for patients with acute myocardial infarction (AMI). (2.5 refers to the ability of the device to augment the cardiac output by 2.5 liters per minute.) We've been following Impella, a ventricular assist device designed for percutaneous placement in the catheterization lab, for at least four years now, ever since it was designed and manufactured by Impella CardioSystems AG of Germany.
From today's announcement:
The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP). According to a recent American Heart Association report, approximately 865,000 AMI patients are treated annually in the U.S. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).The randomized study, at up to 150 hospitals, is comprised of two arms; those patients that receive the Impella 2.5 for up to five days as a left ventricular assist device (VAD) and patients that receive IABP therapy. The study will compare 192 Impella 2.5 patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI. These major events include but are not limited to: death, acute renal failure, and need for a major cardiovascular operation. The secondary endpoint will be a composite of cardiac function such as ejection fraction, requirement for inotropic support and cardiac power output. Following Institutional Review Board (IRB) approval at each participating hospital and requisite training, the Company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites.
Check out the product brochure below:
Press release: Abiomed Receives Conditional FDA Approval for Impella 2.5 Study for Acute Myocardial Infarction (AMI) Patients...
Product page: Impella 2.5...
Flashbacks: impella® recover LV ; Impella Recover Devices Approved in Germany for Reimbursement
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Tuesday, March 11, 2008
REPLY, World's Smallest Pacemaker OK'ed in Europe
The world's smallest dual chamber pacemaker from Italian firm The Sorin Group has received EU's CE Mark of approval, and now has been implanted in the first patient, according to the company. The 8cc device sports the company's proprietary pacing mode, SafeR™:
Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation, two conditions that can prove fatal and place a heavy cost burden on healthcare systems.While conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50 to 80 percent of the time, SafeR™ reduces pacing in the ventricle to less than 0.1 percent in the same patients. Heart block is an electrical conduction disorder that results in the inability of the atria and ventricles, the heart's chambers, to beat in a synchronized way.
In addition to SafeR™, the REPLY™ pacemakers bring together advanced, automatic features that provide easier patient management by simplifying device checks.
The first REPLY™ pacemaker implants were successfully performed by Dr. Georg Noelker, M.D., in the Internal Medicine Department headed by Professor Johannes Brachman, M.D., Klinikum Coburg, Germany and by Dr. Ezio Aimé, M.D., at the IRCCS Policlinico of S. Donato, Milan.
Professor Brachman commented: "I've been using the first generation of SafeR™ since its introduction in 2003. This exclusive pacing technology has brought tremendous benefits to my patients who are now given chances to rely on their heart's natural conduction when it is intact. I really appreciate SafeR™ because it
provides optimal pacing therapy to my patients." The SafeR™ technology builds on the Sorin Group's proven AAIsafeR™ mode, the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR™ was first launched in September 2003 in Europe and received FDA approval in May 2005. Sorin Group was the first company to receive U.S. market clearance for a pacemaker incorporating a pacing mode that minimizes ventricular pacing.
Product page: REPLY...
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Monday, March 10, 2008
Edwards Sapien Transcatheter Aortic Valve Makes Human Debut
Edwards Lifesciences is reporting that the first three human implants of the next-generation Edwards transcatheter aortic heart valve, dubbed Edwards Sapien THV, were performed by John Webb, M.D., director of the cath lab and cardiac intervention at St. Paul's Hospital in Vancouver, BC. This percutaneous valve, conceived for the treatment of severe aortic stenosis, could be delivered via transfemoral approach (with the RetroFlex delivery system) or via transapical placement (with the Ascendra delivery system). The picture below illustrates the transapical approach.
Edwards' next-generation balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient's vasculature for delivery of the valve without open-heart surgery. The new valve will also be offered in additional sizes and builds upon Edwards' more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies.
Edwards is the only company currently engaged in a U.S. clinical trial of a transcatheter aortic heart valve. The Edwards SAPIEN valve with both the RetroFlex transfemoral and Ascendra transapical delivery systems is being evaluated in the PARTNER (Placement of AoRTic traNscathetER valves) pivotal trial for U.S. Food and Drug Administration (FDA) approval.
"We estimate that for every patient who receives an aortic valve replacement, there is another who goes untreated; half of these untreated patients with severe symptoms will die within two years," said Craig Smith, M.D., chief of the division of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial. "Soon physicians will be able to treat virtually all high-risk aortic stenosis patients with transcatheter valves, delivered transapically or transfemorally, as we continue to carefully study the long-term performance of this technology."
Product page: Edwards SAPIEN Transcatheter Heart Valve...
Press release: Edwards Lifesciences Announces First Human Implants of Next-Generation Transcatheter Heart Valve...
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Friday, March 7, 2008
FloWave 1000 Monitor Promises Noninvasive Cardiac Output
One EKG lead. One pulse oximeter. Some secret stuff. And presto! Profit... and, of course, noninvasive cardiac output monitoring. Woolsthorpe Technologies, a Brentwood, Tenn. company, 
is reporting that its hemodynamics device FloWave 1000 is now being evaluated in clinical trials in Vanderbilt University Medical Center and in Saint Thomas Research Institute in Nashville, and in the Texas Heart Institute in Houston. The device, based on a single paired ECG lead, dual pulse oximetry sensor, and a secret proprietary algorithm, is designed to extrapolate patient's cardiac output, cardiac index, stroke volume, heart rate, saturation, and more.
The device has been around for at least 4 years now, as this article from 2004 in Nashville Business Journal testifies. But since the company is putting out perky press releases, and The Tennessean reports about the company as the greatest thing since the sliced bread, our pulse and cardiac output go up slightly. Let us hope there is enough blood flow in the company to deliver on its promises.
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Thursday, February 14, 2008
Motorized Fabric for Cardiac Assistance
Today's cardiac assist devices suffer from a number of problems including immune system attacks, destruction of blood cells by the pump, and others. At Leeds University, researchers have created a webbed fabric, aka artificial myocardium, that can contract and squeeze the heart from outside, while not coming directly in contact with blood.
The webbing wraps around the heart and therefore does not come into contact with the blood stream. Inbuilt sensors recognise when the heart wants to beat and trigger a series of miniature motors which cause the web to contract – increasing the internal pressure and assisting the heart to pump the blood around the body...“It’s a really simple concept that works in the same way as when you squeeze a plastic bottle, forcing the liquid inside to rise,” says PhD student David Keeling who has built a special rig to test the device.
The device is currently at prototype stage with team using a computer simulated model of the human blood flow circuit coupled to David’s mechanical rig. The rig replicates the motion of the heart within the simulation under different conditions, and allows the team to test their web device. The group is currently testing their latest prototype, aiming to refine design and assist strategies. Says David: “We’ve been looking at finding the optimum timing to trigger and also length of the compressive squeeze.”
Once the mechanics have been perfected, the team intends to simulate the effects of different heart diseases to gauge the potential success of the device.
Press release: Web will work wonders for the faint hearted...
Cardiac Assist Project Homepage ...
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Friday, February 8, 2008
CryoValve Approved by FDA
The FDA has given approval to CryoValve® SG pulmonary human heart valve, an allograft based on CryoLife's SyneGraft® technique that removes cells and cell fragments from cadaveric heart valves. The remaining matrix is thought to be less prone to attack by the immune system.
Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft product remains otherwise unchanged. CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection."Today's clearance is a promising advance in allograft products," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA welcomes innovations in manufacturing that provide more medical options for patients."
Allograft (human) heart valves are popular choices for children because they avoid the need to take blood-thinning medications on a long-term basis. Allograft heart valves are also less likely to calcify than heart valves from a pig or cow.
FDA press release: FDA Clears for Market First Decellularized Heart Valve
CryoLife press release: CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
Product page: CryoLife : CryoValve® SG Pulmonary Human Heart Valve
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Monday, February 4, 2008
German Team Wants to Improve Safety of VADs
Prof. Dr. Holger Schlingloff and colleagues at the Fraunhofer Institute for Computer Architecture and Software Technology (FIRST) in Berlin (Fraunhofer-Institut für Rechnerarchitektur und Softwaretechnik) is working with Berlin Heart AG, a maker of ventricular assist devices, on developing "a model-based test system to guarantee the functional safety of cardiac support systems."
“It is impossible to prove that a system is entirely failure-proof by simply running a test – it could be that certain types of fault have been overlooked,” says Rolf Hänisch, project manager at the Fraunhofer FIRST. “We can eliminate this shortcoming by producing systematized tests based on models, in which we record and simulate all relevant test scenarios.”There are two approaches to modeling this type of system. The first takes its point of departure in the intended application, asking “how will the device be operated in clinical practice?” and “how does the software interpret the physician’s instructions?”, for example. The second approach starts by looking at the software’s source code, for instance “which part of the code is responsible for which functions?”. Since even experts can inadvertently skip a line when reading code, the team has developed an automated program to help them locate safety-critical sections. The new technology will be presented to trade fair visitors at embedded world in Nuremberg from February 26 to 28 (Hall 12, Stand 12-138) and at CeBIT in Hanover from March 4 to 9...
Flashbacks: Berlin Heart EXCOR ; German-made Heart Pump for Children Needing Heart Transplants
Press release: Relief for diseased hearts ...
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Wednesday, January 30, 2008
OrNim's Targeted Oximetry
OrNim, a Lod, Israel company, has developed a non-invasive laser-based sensor for direct monitoring of oxygen levels within the brain. The company is trying to break into a lucrative market of cerebral perfusion monitoring, currently dominated by such devices as INVOS Cerebral Oximeter from Somanetics Corp. Unlike its competitiors, OrNim believes its monitor could potentially be used for monitoring a variety of organs, from brain to viscera.
From the company's technology page:
... pulse oximetry is an optical based technology that is used to measure oxygen levels within the arterial blood. It works by attaching a non-invasive probe to a patient (usually placed on the ear, finger, or toe) which transmits a beam of light through the patient’s blood vessels. This technology works by measuring the differences in absorption of different wavelengths of light by oxygenated and deoxygenated hemoglobin. Pulse oximetry has markedly improved medical care – particularly in the fields of anesthesiology and intensive care – and as a result has been rapidly adopted by the medical community. However, pulse oximetry is subject to a number of limitations – most notably, the technology cannot penetrate deep tissue, it is sensitive to ambient light levels and remains limited to peripheral perfusion (e.g. the finger). Tissue oximetry, a technology capable of penetrating deep tissue, remains qualitative in nature (i.e. it cannot provide an absolute measurement of blood oxygen saturation).OrNim is introducing a breakthrough technology that enables localized, quantitative measurements of oxygen saturation levels from deep tissue volumes. OrNim’s sensors are capable of performing Targeted Oximetry - allowing caregivers the ability to pinpoint specific regions of the body, bypass peripheral tissue, and measure oxygen saturation levels within the monitored tissue.
The ability to locally monitor tissue oxygenation is particularly important in the instance of monitoring oxygen saturation within cerebral tissue. The Company’s technology is capable of filtering out the contribution of external tissue to the measured signal - thereby providing a “clean” reading of oxygen saturation from only the tissue that is targeted.
This is a revolutionary application as prior methods of quantitatively measuring oxygen in specific deep tissue tended to be invasive (i.e. requiring a surgical procedure), narrowly localized, and subject to environmental interference.
In addition to monitoring tissue oxygenation, Targeted Oximetry is inherently capable of monitoring other vital parameters. As a result, the technology can also be used to detect the presence and extent of hemorrhages within the monitored tissue, or changes in blood perfusion to the tissue.
With quantitative cerebral oximetry, patient outcome can be improved. Additionally, intensive care (ICU) patient stay and costs associated with patient treatment can be significantly reduced. It is essential to determine a patient’s absolute oxygenation for managing his/her therapy. In cases where the patient’s condition is unknown prior to start of procedure, qualitative modalities are inefficient.
OrNim’s first product will assist physicians in preventing and reducing neurological damage that frequently occurs during traumatic brain injury, stroke, or following cardiac arrest.
More at MIT Tech Review...
Company page: OrNim...
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Tuesday, January 29, 2008
New OR Computer and JOCAP XL Program from MAQUET
MAQUET GmbH & Co. KG from Germany has release a new version of JOCAP XL 7.1 for its popular online recording system that "allows the perfusionist to turn his attention to what really matters." The software is designed to run on the company's new OR Computer, reports German Healthcare Export Group:
JOCAP XL has become established as the standard thanks to its comprehensive display and evaluation options as well as its open interfaces to other systems. The system includes interfaces to all common heart-lung machines and other peripheral devices, such as blood gas analysis and anesthesia monitors. Together with the new OR Computer, JOCAP XL offers advantages.The program can now be operated via a touch screen and, if required, a keyboard is displayed on the 15” screen to allow data to be entered. As there is no need for an external keyboard, cleaning of the OR Computer is easier and any clutter at the perfusionist’s workstation is kept to a minimum.
According to the manufacturer, the OR Computer is the only device of its kind with an integrated emergency power supply which ensures that the system remains fully functional even in the event of a short-term power failure; it also goes without saying that the system meets all medical standards. The OR Computer can be directly connected to the hospital’s information system via LAN connections (Ethernet) allowing data for administration and archiving to be exchanged easily. Furthermore, the OR Computer has manifold inputs for network, USB and audio connections. Data can also be optionally saved to CD-ROM and DVD using the integrated burner.
The well-known JOCAP XL user guidance system has been further optimized. Using the clearly laid out directory, the individual input screens and displays can be selected directly in the drop-down selection menus. Perfusionist’s also set great store by the overview module, which allows all the important parameters to be checked at a glance on a single display; individual displays no longer have to be called up. The data is synchronously updated every 12 seconds and displayed in both graphic and tabular format. Prior to the operation, the perfusionist imports patient data including age, height, weight and patient number from the HIS. Alternatively, these can be entered manually or edited. This information is recorded together with details on the OR team and the devices, disposable products and implants used. In addition, the patient’s history, potential risk factors, allergies and medication are also entered. Input screens to mark important events during the operation such as the opening and closure of the thorax, cannulation and the admixture of medication are also important for the purpose of documentation. Alongside recording and monitoring, JOCAP XL offers a wide range of possibilities for statistically printing and evaluating the recorded data for comparisons and reports.
Product page: OR COMPUTER ...
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SPY Intra-operative Imaging System for Graft Assessment
Novadaq Technologies Inc., an Ontario, Canada-based company, is reporting that its Spy system and other company technologies, such as real-time autofluorescence bronchoscopy, were discussed at an educational program for cardiothoracic surgeons during the ongoing 44th Annual Society of Thoracic Surgery (STS) meeting in Fort Lauderdale, Florida. SPY is an imaging system for intra-operative fluorescence vascular angiography, designed to confirm the patency of grafts during coronary artery bypass grafting, and to assess the coronary vasculature to confirm the location of target vessels.
Here's what the company says about the presentation mentioned above:
Dr. Patrick Ross stressed the clinical importance of using autofluorescence imaging to provide guidance during endoluminal and traditional surgical treatments for lung cancer. Dr. Ross reported the use of real-time autofluorescence bronchoscopy, compared to the gold standard white light bronchoscopy, provides for a more detailed assessment of the patient's anatomy before pulmonary resection, a more accurate assessment for the presence of early lung cancers and the ability to more precisely perform endoluminal therapies such as Photodynamic Therapy. Dr. Ross also reminded the cardiothoracic surgeon audience that autofluorescence bronchoscopy is now recommended in the 2008 American College of Chest Physicians Evidence Based Practice Guidelines for use in detecting cancerous lesions and for guiding surgical treatments in patients with lung cancer.Professor Taggart reported his clinical experience using the SPY Intra-operative Imaging System to optimize the clinical outcomes of his coronary artery bypass procedures, which have been previously published in the literature and confirm the need for intra-operative graft assessment. Professor Taggart's presented clinical results of studies he has performed using SPY. Data reported by others indicating that as many as 30% of all vein grafts may be closed at 1 year post bypass were also included. Professor Taggart stressed that coronary artery disease has become more complex, making coronary artery bypass surgery more technically demanding, which further increases the need for real-time assessment of graft quality. Professor Taggart reported on studies of the clinical utility of available technologies for graft assessment, including a report by Nimesh Desai, MD., et.al, published in The Journal of Thoracic and Cardiovascular Surgery in 2006. The randomized study compared SPY and the Transit Time Flow Meter, the two most commonly used tools, to the gold standard x-ray angiography. In the study of 139 bypass grafts, SPY was found to result in 83% sensitivity and 100% specificity compared to 25% and 94% respectively for the Transit Time Flow Meter.
To learn more about the Spy and real-time autofluorescence bronchoscopy, head