ProSound Alpha 6, a color ultrasound system from ALOKA of Tokyo, Japan is making its U.S. debut at the American Congress of Obstetricians and Gynecologists (ACOG) Conference in San Francisco this week.
This latest addition to the ProSound Alpha series features advanced 3D/4D imaging, harmonic imaging, directional eFLOW, image optimization, adaptive image processing, spatial compound imaging, color flow, power flow, spectral Doppler, free angular M-Mode, and an extended field of view. Some of these imaging modes were previously seen only in high end systems. The α-6 boasts an award-winning ergonomic design with a large, programmable touch screen, height adjustable control panel and swivel/tilt LCD monitor. The system is released with a full suite of application-specific probes and software, customizable reports and network/EMR connectivity capabilities for general imaging, cardiovascular, obstetrics and gynecology, and internal medicine.
Press release: ALOKA Ultrasound Announces U.S. Debut of ProSound Alpha 6…
Product page: ProSound Alpha 6…
Archives: 5/2010
Entirely Subcutaneous Implantable Cardioverter-Defibrillator Showing Promise in Clinical Study
by on May 13, 2010 • 12:00 am
No lack of news on the implantable cardiac devices front these days. A team of researchers from all over the world have published their experience with a completely subcutaneous ICD from Cameron Health (San Clemente, CA) in this week’s New England Journal of Medicine. The researchers eliminated the transvenous pacing lead, implanting the lead subcutaneously and tested various configurations for their effectiveness. The pacing lead is a major source of complications of ICDs due to problems during insertion and long-term failure. In the end clinicians found a parasternal electrode and a left lateral thoracic pulse generator to be the optimal configuration, as effective as transvenous ICD for terminating induced ventricular fibrillation. In addition, the device successfully detected and treated 12 episodes of spontaneous ventricular tachyarrhythmia in patients enrolled in the study. One issue to consider is that the energy required for the shock was significantly higher than traditional ICDs. Additional disadvantages of the device is that it cannot perform long-term pacing and cannot treat ventricular tachycardias of less than 170 beats per minute.
From the article abstract in The New England Journal of Medicine:
Methods First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients.
Results The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean (±SD) energy requirement (36.6±19.8 J vs. 11.1±8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Induced ventricular fibrillation was converted twice in 58 of 59 patients (98%) with the delivery of 65-J shocks in two consecutive tests. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10±1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia.
Conclusions In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted ventricular fibrillation induced during electrophysiological testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia.
Press release: Research Published in the New England Journal of Medicine Highlights Potential Benefits of Cameron Health’s S-ICD System…
Product page: Cameron Health S-ICD System…
Full article in NEJM: An Entirely Subcutaneous Implantable Cardioverter-Defibrillator
Flashbacks: EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator; Subcutaneous Implantable Cardiac Defibrillators
St. Jude Medical has launched the Promote Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet pacing lead in Europe. It is the first available quadripolar pacing system, which means that the left ventricular pacing lead has four pacing electrodes which can be used in different combinations or pacing configurations. This allows for placement of the lead in the most stable position, after which the different pacing electrodes can be enabled or disabled to reach the most optimal pacing pattern. In addition to simplifying lead placement, this also can be used to work around scar tissue, and to avoid having to pace at suboptimal locations where high pacing thresholds are present. Those in the United States have to wait a little longer, as there is an investigational device exemption trial ongoing.
Press release: St. Jude Medical Announces European Launch of Industry’s First Quadripolar Pacing System…
Rather goofy-looking at first glance, Honda’s new legs (aka Bodyweight Support Assist Device) makes walking and stair-climbing easier for the elderly and folks on rehab. 
Leveraging walking technology from full-body ASIMO robot, the leggy device provides natural walking and crouching support with its combined saddle, motorized leg frame and force-sensing shoes. With a control computer and battery pack neatly tucked away under the femur of the frame, the legs sense and guide motion while walking, going up and down stairs and in a semi-crouching position. An assisting force is directed towards the user’s center of gravity and in sync with movement to support one’s bodyweight and reduce the load on the user’s leg muscles and joints.
The legs are on display at the Cooper-Hewitt, National Design Museum, Smithsonian Institution in New York starting May 14th.
The prototype, as of Nov. 2008, weighs 14.3 lbs including shoes and batteries, operates for 2 hours on a single charge of a lithium ion battery, and comes in three sizes for users of roughly 5’2″, 5’6″ and 6′ in height. More than 130 patents have been applied by Honda to its walking assist devices, which are currently being tested in real-world conditions to evaluate their effectiveness. Honda’s other walking assist device will not be on exhibit.
Press release: Honda Bodyweight Support Assist Device Selected for Innovation Exhibit at Smithsonian’s Cooper-Hewitt, National Design Museum…
Product page: Honda Walk Assist
Blasts from our past: The Future of Legs Is Here, Well, in Detroit, Honda Makes Public New Robotic Walking Assist Device, Honda Walking Assist Device Update: Feasibility Testing, Honda Makes Public New Robotic Walking Assist Device
Boston Scientific announced today that its TAXUS Element drug eluting stent has been granted the CE Mark, and will consequently be launched in Europe next month. The stent utilizes the same unique platinum chromium alloy and structure as the PROMUS Element stent which we reported on last October, and demonstrated superior performance to the company’s TAXUS Express2 stent in a clinical trial.
From the press release:
The TAXUS Element Stent is designed specifically for coronary stenting and leverages the performance advantages of the Element platform with a decade of clinical success from the TAXUS program. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.
Press release: Boston Scientific Announces European Approval of Platinum Chromium TAXUS® Element™ Stent System…
Flashback: Boston Sci’s PROMUS Element Stent Gets Go Ahead in Europe
St. Jude Medical has received approval from the Japanese authorities for its AnalyST implantable cardioverter defibrillator (ICD) with ST Monitoring. Apart from the normal functions of an ICD, this device continuously monitors the intracardially recorded ECG for ST segment changes. The company claims that this will allow detection of otherwise silent ischemic episodes and will reduce the risk of false positive and false negative ECG’s. The device saves a continuous recording which can be retrieved by the doctor at the next follow up visit. In the future, St. Jude also plans to connect the device via their Merlin@home telemonitoring system in order to receive alerts when any significant changes occur.
Other features (from the press release):
DeFT Response(R) technology – which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia. VIP(R) (Ventricular Intrinsic Preference) algorithm – provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient’s own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients’ overall heart health. SenseAbility(R) technology – which is designed to optimize sensing to help protect against inappropriate shocks.
Vibrating patient notifier – The industry’s only notifier that gently vibrates – instead of issuing the standard audio alert – to notify patients if the device is not performing as designed; this can be especially beneficial for people with hearing loss.
Press release: St. Jude Medical Announces Japanese Approval of Life Saving Implantable Device that Continuously Monitors Electrical Changes that Signal Cardiac Problems…
Product page: AnalyST Accel…
Earlier we wrote about the GeNO Nitrosyl NO Delivery Device. However, a rep for the company has written in with a clarification that the image we showed was not the device cleared for investigative use. The stand-alone gas cylinder pictured is what was approved.
Here’s from an email sent to us by a representative for GeNO LLC:
the ambulatory (belt-clip sized) system is one of 3 Nitrosyl platforms and has not entered trials or the clinical setting yet: there is
1) the stand alone gas cylinder (which just got the IND cleared and will enter (phase) 2, first as a diagnostic in pulmonary arterial hypertension, per the release and my note);
2) a ventilator system; and
3) the ambulatory system. From the lead I just did not want confusion that the system in the photo is what we issued in our IND release– that system is a downstream technology in the various Nitrosyl platforms.
…the portable size is very interesting given all of the treatment difficulties you describe, I just wanted to be clear that GeNO is starting first with the stand-alone gas cylinder in trials (recent IND cleared), and this is exciting because it opens the door to further resarch and allows GeNO to move their other technologies and platforms (like the ambulatory) into development.
Flashback:GeNO Nitrosyl NO Delivery Device Moves to Phase 2 Testing…
DARPA is stimulating the development of implantable therapies for brain trauma with $14.9M of federal funding towards optogenetics research. Led by optogenetics pioneer Karl Deisseroth at Stanford University, the REPAIR research team will study the response of neural microcircuits to injury and develop implantable optogenetic microdevices that may help the brain restore function.
A highly-specific type of neuromodulation, optogenetics can switch neural activity on and off with a small implanted device that delivers green and yellow laser signals via fiber optics onto their respective light-sensitive genes, channelrhodopsin 2 (ChR2) and halorhodopsin (NpHR). Optogenetic signals are highly discriminant, unlike current deep brain stimulation (DBS) therapies, and pulses at the frequency at which neurons operate. The genetically-engineered cells in turn regulate the activity of specific neural circuits, such as those that play a role in Parkinson’s, blindness, spinal injury, narcolepsy, addiction, and memory.
According to Technology Review, over 500 laboratories today are applying optogenetic tools to animal models. Optogenetics has also garnered commercial R&D and prototyping at Medtronic to improve on its portfolio of electrical stimulators.
From a Stanford press release:
In REPAIR, the researchers will use optogenetics to produce completely reversible “injuries” in the brains of research animals, by temporarily turning off specific parts of the brain. They will then study how the brain might rewire itself to deal with that tissue becoming unavailable, said Karl Deisseroth, associate professor of bioengineering and of psychiatry and behavioral sciences at Stanford, who pioneered optogenetics.
“There are many advantages to using optogenetics instead of drugs or lesions,” Deisseroth said. “You are in no way injuring the animals, because as soon as you turn the light off they are back to normal, and it is also a lot cheaper, easier and more precise to use.”
The interdisciplinary team draws upon researchers from four universities in neuroscience, neurology and psychiatry to semiconductors, optoelectronics, statistical signal processing, machine learning and brain modeling.
Press release: New Stanford-led program aims to produce insights into brain injury, recovery…
Tech Review article on Medtronic’s R&D in optogenetics: A Brain Implant that Uses Light
Flashbacks: Optogenetics Focuses on Parkinson’s Treatment; Scientists Optically Deconstruct Parkinsonian Neural Circuitry; Fiber Optics Activate Neurons, Axons to Answer Parkinson’s Questions
Adipose-Derived Stem Cells Show Promise in Treatment of Chronic Ischemia
by on May 12, 2010 • 12:00 am
San Diego, CA based Cytori Therapeutics has announced the results of their PRECISE trial, in which patients with severe cardiomyopathy were treated with autologous adipose-derived regenerative cells (ADRCs). The ADRCs were obtained using Cytori’s Celution system (which we previously covered here at Medgadget; see below), and were then injected into each patient’s heart. At six months after the procedure, patients had improved oxygen consumption and aerobic capacity when compared to the control group. The international 27 patient study, conducted at Hospital Universitario Gregorio Marañón (Madrid), Texas Heart Institute and Erasmus University Hospital, was just presented at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain.
Conclusions from the study, via press release:
Liposuction and cell injection were safe in these severely compromised patients, with no serious adverse events (arrhythmia or major adverse cardiac events) MVO2 showed a statistically significant improvement from baseline to six-months in the cell treated group as compared to placebo. MVO2 is a clinically relevant prognostic factor in heart disease and is commonly used as a contributing measure to stratify patients for heart transplant The results showed absolute increase (improvement) in MVO2 by 0.6 mL/kg/min in the treated group versus 2.8 mL/kg/min decrease (worsening) in the placebo group from baseline to six-months, based on matched-pair analysis. This difference was statistically significant (p < 0.05). This analysis excludes two patients whose follow up MVO2 results were not available For the entire cohort of patients, mean MVO2 improved from 16.6 mL/kg/min at baseline to 17.2 mL/kg/min at six-months in cell-treated patients, and worsened from 19.0 mL/kg/min to 15.5 mL/kg/min in the placebo group METS (metabolic equivalent), a measure of the patient’s aerobic capacity, improved by 0.2 points from baseline to six-months in the cell treated group compared to a decrease of 0.8 points from baseline to follow up in the placebo group based on matched-pair analysis; the difference was statistically significant (p < 0.05) The percent of left ventricle infarcted, the portion of the heart not receiving blood to support pumping, decreased (improved) by 3.0% in the cell treated group compared to an increase (worsening) of 5.2% in the placebo group, an absolute difference of 8.2% Improvements in New York Heart Association Functional Class, which classifies the severity of heart disease on a scale of one to four, were observed in 63% of patients treated with cells as compared to observed in 33% of patients in the placebo group
Press release: Cytori Reports Stem & Regenerative Cells from Body Fat Produce Statistically Significant Improvement in Heart Function in Chronic Ischemia Trial…
Cytori Therapeutics…
Flashbacks: The Celution System; Celution System Wins FDA Approval; Found to Fix Breast Defects
