Cardiology Archive

Thursday, November 19, 2009

My Lab One Portable Ultrasound from Esaote Makes Debut

At the ongoing Medica 2009 in Düsseldorf, Esaote out of Genoa, Italy is releasing a new portable ultrasound system that features a 12 inch touch screen for manipulating settings without having to use buttons. The My Lab One can be worn on a shoulder strap and is designed for mobile applications such as ambulatory anesthesia, EMT, military and sports medicine.

From the press release:

The automatic rotation of the image according to the position of the system, an ergonomic probe equipped with controls, a long life battery, all add up to making this ultrasound an extraordinary innovation in the medical system arena.

MyLab One is a “dedicated” ultrasound, which reflects perfectly today’s need for diagnostic capabilities in many different fields of application: from Radiology to Cardiology, from to Orthopaedics, Anaesthesia, Sports Medicine, etc… or in first-aid, emergency, vascular screening as well as in general practices.

Press release: Esaote presents “My Lab One” Innovative “wearable” ultrasound scanner ARM HELD

Product page: Esaote ultrasound...

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Monday, November 16, 2009

Merit Laureate Guide Wire Going to Market in US


Merit Medical Systems out South Jordan, Utah received 510(K) clearance from the FDA for the Merit Laureate hydrophilic guide wire.

"This product will be sold in both our cardiology and radiology sales points," Lampropoulos added. "Procedures that include drainage catheter access, dialysis catheter placement as well as difficult vascular access procedures commonly use hydrophilic guide wires."

The Merit Laureate(TM) guide wire is fabricated from a unique core nitinol wire, covered with a urethane jacket and coated with a proprietary process that produces a slippery surface. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy.

Press release: Merit Medical Announces 510(K) Clearance for the Merit Laureate(TM) Hydrophilic Guide Wire ...

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Thursday, November 12, 2009

FDA Grants Vascular Solutions Clearance for The GuideLine Catheter


US FDA has given 510(k) regulatory clearance to Vascular Solutions Inc., a Minneapolis, Minnesota firm, to market the GuideLiner™ catheter. The device, designed to provide a coaxial guide extension and rapid exchange for coronary or peripheral interventions, comes in 6F, 7F, 8F (Freedom Fries) sizes and is delivered through standard guide catheters, hence it allows physicians to use "standard length guidewires, balloons or stents through an existing hemostatic valve," according to the company.

From the press release:

The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.

Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”

Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”

Press release (.pdf)...

Product brochure: GuideLiner Catheter...

Product page: GuideLiner Catheter ...

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Tuesday, November 10, 2009

Boston Sci's PROMUS Element Stent Gets Go Ahead in Europe

The EU issued approval to Boston Scientific's PROMUS® Element™ coronary stent based on the platinum chromium alloy.

The platinum chromium alloy used in the PROMUS Element stent is engineered specifically for coronary stenting. This proprietary alloy offers greater radial strength and flexibility than older alloys such as the cobalt chromium alloy used in the XIENCE PRIME™ DES, and it provides enhanced visibility and reduced recoil. The innovative stent design improves deliverability and allows for more consistent lesion coverage and drug distribution. The advanced catheter delivery system further improves deliverability.

The PROMUS Element system is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element system.

Here's Boston Sci's promo video for the PROMUS ELEMENT:

Press release: BOSTON SCIENTIFIC ANNOUNCES EUROPEAN APPROVAL AND LAUNCH OF PLATINUM CHROMIUM PROMUS® ELEMENT™ STENT SYSTEM ...

Product page: PROMUS Element Stent ...

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Monday, November 9, 2009

Toumaz Sensium Digital Plaster Goes on Trial


Toumaz Technology out of Abingdon, UK has announced it partnered with the Imperial College London to perform a clinical trial on the company's "Digital Plaster" vital signs monitor. The technology, which we covered in the past (see flashbacks below), allows for continuous monitoring and wireless transmission of temperature, heart and respiratory rates to help speed up workflow and get rid of some of the cables.

The focus of the trial will be to verify that the physiological data acquired by the digital plaster system within a clinical setting is equivalent to that acquired using current gold-standard monitors in use in hospitals – equipment that is often bulky, expensive and fixed, such that patient mobility is impaired. The Sensium digital plaster is wireless and unobtrusive, meaning that patients can remain ambulatory in hospital while still being monitored. This flexibility allows continuous vital sign monitoring to be extended to patients who would not normally be monitored, thereby offering the potential to increase patient safety. The Sensium digital plaster is a disposable device with a working lifetime of several days, after which the plaster is disposed of in the appropriate waste receptacle.

The trial is being conducted in three phases, an initial phase with non-patient volunteers followed by two patient study groups: patients recovering from surgery, and patients with specific medical conditions in the general wards.

The Sensium digital plaster is targeted for use in clinical monitoring applications such as acute care, general ward environments, tele-care, chronic disease monitoring, and in care home settings. For all these applications, disposability provides convenience, simplicity and patient comfort while ensuring infection control is maintained to the highest standards. Powered by thin batteries, body-worn Sensium-enabled monitors deliver clinical-quality data and intelligently integrate it into an electronic medical record via a network built on Toumaz’s power-optimised wireless operating and networking system, Nano Sensor Protocol (NSP).

Press release: Toumaz Technology and Imperial College London In Landmark Clinical Trial Of Sensium

Product page: Toumaz Sensium ...

Flashbacks: Sensium Life Pebble Wireless Vitals Monitor for Sport Training, Cardiac Health Auditing ; EU Aims to Develop Blood Glucose Prediction Device ; Sensium Chip: An Ultra Low Power Sensor Interface

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Monday, October 26, 2009

Sensium Life Pebble Wireless Vitals Monitor for Sport Training, Cardiac Health Auditing


Toumaz Technology out of Abingdon, UK has released the Sensium™ Life Pebble vital sign monitoring device. Featuring a single lead ECG, a skin thermometer, and an accelerometer to monitor physical activity, the unit can track one's performance for later analysis by a clinician.

Device features:

  • Wireless monitoring of heart rate and activity optimised for ambulatory conditions
  • Accurate electrically-derived heart rate from R to R peak measurements
  • 3-axis accelerometer to detect and measure physical activity
  • Skin temperature sensor
  • Robust data communication, even in noisy channels
  • Up to 5 days' operational use on a single hearing aid battery
  • Light weight and ultra-small size (20gm with LR44 battery, excluding EKG leads)
  • Press release: Toumaz Technology Announces Availability of Sensium Life Pebble Wireless Vital Signs Monitor...

    Product page: The Sensium Life Pebble...

    Flashback: Sensium™ Chip: An Ultra Low Power Sensor Interface

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    TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems


    Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.

    The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.

    Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.

    Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...

    Product pages: TruSystem 7500, Artis zee, Artis zeego

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    Wednesday, October 21, 2009

    GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope


    Yesterday at the Web 2.0 Summit in San Francisco, GE showed off their new handheld ultrasound device. The Vscan looks like a cross between an iPod and a cell phone, making it possibly the world's smallest ultrasound. Later today we'll be attending GE's healthymagination technology showcase in New York where further details and specs will hopefully become available.

    For critical care clinicians, Vscan can offer an immediate look beyond patient vital signs with the potential to identify critical issues, like fluid around the heart, which could be a sign of congestive heart failure. And for cardiologists, Vscan provides a dependable visual evaluation of how well the heart is pumping at a glance, so they can treat patients more efficiently.

    More from GE...

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    Tuesday, October 20, 2009

    BIOTRONIK's At-Home Implantable Cardiac Device Monitoring to Go Live in Europe


    BIOTRONIK has received European approval for its implantable device home monitoring system. Designed to avoid regular visits to the clinic by patients wearing company's ICD's, CRT's, and similar devices, the system sends readings from the chest straight to your doc over the cellular phone network.

    BIOTRONIK Home Monitoring® is the first and only fully wireless, mobile remote monitoring system for patients with implantable cardiac devices on the market today. This newly authorized EU approval for BIOTRONIK Home Monitoring® is based on the landmark TRUST Trial which proved that BIOTRONIK Home Monitoring® can safely and effectively replace conventional in-hospital device follow-up visits. Patients can be remotely monitored securely through the BIOTRONIK Home Monitoring® wireless system with only one annual in-clinic visit. In addition, the TRUST trial also demonstrated that BIOTRONIK Home Monitoring® with its automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events and device system anomalies allowing for earlier physician intervention than conventional in-hospital follow-ups.

    By extending the time between routine in-hospital visits for periods up to 12 months, remote device follow-up with BIOTRONIK Home Monitoring® reduces the number of physician consultations in often overburdened cardiology hospitals without negatively impacting patients’ quality of care or safety. Physicians and clinic staff benefit from reduced workloads for routine cases, which allow them to afford greater attention to patients who urgently require a consultation for diagnostics and treatment.

    These new approvals are applicable across the entire BIOTRONIK product portfolio of pacemakers, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices with BIOTRONIK Home Monitoring®.

    Product page: BIOTRONIK Home Monitoring...

    Press release: BIOTRONIK Home Monitoring Receives Industry's First Approval to Safely Replace Hospital Visits for Cardiac Device Follow-ups...

    Flashback: BIOTRONIK Cardiac Monitoring Going Worldwide.

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    CARTO 3 EP System Wins US Regulatory Green Light


    Biosense Webster, a Johnson & Johnson company, has received Food and Drug Administration approval for the CARTO® 3 cardiac electrophysiology system. Features of the device include magneto-electric localization of catheters, high speed 3D cardiac mapping, and a new central connection system for catheters and accompanying equipment.

    ACL is a hybrid technology that allows for accurate catheter tip and curve visualization without spatial distortion. This helps the electrophysiologist to orient catheters with precision for diagnostic and therapeutic applications. The system can visualize up to five catheters simultaneously with clear distinction of all electrodes.

    FAM is a leading-edge technology that quickly and accurately creates high-resolution, CT-like maps as quickly as an EP can move his or her catheter throughout the cardiac chamber. FAM technology also permits detailed visual enhancement of a specific area of interest within the heart.

    Connection of Choice™ is enabled by the brand new Carto® System hardware configuration featuring a central connection point for all catheters and equipment while preserving the signal quality of intracardiac electrograms. Catheter connections have been re-designed for “plug-and-play” functionality and automatic catheter recognition. All of these enhancements have been developed to streamline and simplify workflow in the EP lab.

    Press release: Biosense Webster Receives FDA Clearance For The CARTO® 3 System...

    Product page: CARTO 3 System...

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    Tuesday, October 13, 2009

    Guardian II Hemostasis Valve Gets FDA Nod


    The FDA has granted approval to the Guardian II™ Hemostasis Valve produced by Zerusa, a Galway, Ireland firm. The valve, designed for easy movement of catheters and other interventional angio devices while providing hemostasis, has already been approved in Europe. The device will now be distributed in the US by Vascular Solutions out of Minneapolis, MN.

    Features from the product page:

    Unique Seal Technology

  • Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.

  • Allows separation of guidewires and other devices during complex procedures.
  • Click-open and Click-close Design

  • Allows single handed operation

  • Unique proximal cap is easily depressed for both opening and closing the lumen.

  • Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.
  • Ergonomic Design

  • Practical design allows the Guardian to fit comfortably in a physician’s hand.

  • Subtle finger tabs have been added for improved handling characteristics.

  • Actual device length 92mm.
  • 8 French Lumen

  • Allows multiple or large therapeutic devices to be inserted during procedures.
  • Secure Device Lock

  • Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.
  • Here's a demo animation showing how one operates the device...

    Press release: Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve...

    Product page: Guardian II™...

    Guardian II™ brochure...

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    Monday, October 5, 2009

    Tiny Portable Ultrasound from SonoSite Gets US OK

    sonomax.jpg
    SonoSite (Bothell, Washington) just announced that the company received FDA approval to market the firm's tiny NanoMaxx ultrasound system throughout the United States. Weighing in at only 6 pounds (2.7 kilo) and with a battery life of 2 operational hours, the system is truly portable for busy clinics, ambulances, emergency rooms, and elsewhere that ultrasound is needed.

    sono34343.jpg

    The new ultra portable and one button design of the NanoMaxx system makes high quality ultrasound available to a much broader range of clinicians. The system incorporates SonoSite’s advanced proprietary imaging algorithms, including SonoMB™ and SonoAdapt™ to deliver superior image quality in a lightweight, rugged form factor.

    With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.

    At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.

    For convenience and flexibility, the system can be wall mounted, placed on an exam table with kickstand attached, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.

    The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, plus magnesium outer shell, allows it to be used in the most demanding and austere environments. Proving its reliability, the NanoMaxx system and its transducers successfully passed SonoSite’s standard three foot durability drop test.

    In addition, to further reduce the risk of infection, the NanoMaxx system’s fluid-resistant user interface makes the system easy to clean and disinfect, helping to address the growing concern over infection control in the medical community.

    Press release: SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool

    Product page: NanoMaxx

    Flashback: NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled

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    Monday, September 28, 2009

    Using the Xbox 360 for Cardiac Research

    8646344.jpgMicrosoft Xbox 360 not only can stimulate your mind, but it also is now being used to investigate cardiac abnormalities.

    Dr. Simon Scarle, a University of Warwick researcher, has detailed his work in using the Graphical Processing Unit (GPU) of an Xbox 360 to model and simulate cardiac arrhythmia in the hopes of understanding their initiation and propagation, so as to develop better treatments. While computer modeling has been around for decades, the breakthrough in this work is using a faster, cheaper, and commercially mass produced computer to accurately model the complex cardiac electrical system. Normally this type of modeling is constrained to supercomputers and must compete for computational time with a whole host of other important scientific modeling applications.


    Snapshot of the graphical image display showing the outward action potential passing around a cardiac block and the return of the action potential. (Image from Scarle; 2009)

    Scarle undertook this work while a software engineer at Microsoft's Rare Studio and modified the GPU to display tracking data of how electrical signals in the heart move around damaged cardiac cells. This creates a visual model of tissue to allow clinicians to identify cardiac conditions such as arrhythmia.

    "These game consoles aren't just glorified toys. [They] are pieces of very powerful computing hardware," Scarle says. "I can see this ... being most useful for students and early-career scientists to just quickly and cheaply grab that extra bit of computing power they otherwise wouldn't be able to get."

    Scarle developed this project as a fusion of his background as a software engineer in gaming and his past experiences with performing electrocardio-dynamics research at the University of Sheffield. He says that the idea for this heart-modeling project came from a "little shooter game" he developed while at Microsoft in which the player would gun down enemies in an arena that resembled a heart.

    Now, if you will excuse us, we will be getting back to our ground breaking cancer research by playing HALO...

    University of Warwick press release: Researchers using parallel processing computing could save thousands by using an Xbox...

    Time : How Xbox Can Help Fight Heart Disease...

    Microsoft Research : Implications of the Turing Completeness of Reaction-Diffusion Models, informed by GPGPU simulations on an XBox 360: Cardiac Arrhythmias, Re-entry and the Halting Problem...

    Flashback : Dr. Halo: XBox Based "Care Consoles" to Invade Hospitals

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    Thursday, September 24, 2009

    Abiomed Reports New Positive Impella 2.5 Results


    The latest results from trials examining Abiomed's Impella 2.5 Percutaneous Circulatory Support System, the world's smallest left ventricle heart pump, are in, and they give the company, us and hoping clinicians a happy feeling. The big hurdle that the company has to overcome is to convince cardiologists that Impella devices are easy to place under difficult circumstances (such as developing high-risk PCI, MI in cath lab, failing ventricle), and are safe for patients. Also, Abiomed has to prove to cardiologists that Impella provides a clinical advantage versus intraaortic balloon pumps (IABP), when a patient's heart is failing and needs an emergency ventricular support in the cath lab. On both of these points, it seems the company scored positive results in the latest trials.

    From Abiomed's press office:

    USpella [is] the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).

    High-Risk PCI patient results in USpella

  • In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5

  • The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5

  • Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support

  • Reported overall MACE was low at 6%

  • 30-day survival rate was 97%
  • AMI patient results in USpella

  • Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy

  • Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR)

  • After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%;

  • Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged
  • The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.

    All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:

  • Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points.

  • Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient

  • Impella 2.5 patients saw no effects on aortic valve at three-year follow-up
  • Press releases: Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval...; Abiomed Reports Results from Academic Medical Center's Three-Year Follow-up of MACH II Trial...

    More thoughts from MassDevice...

    Flashbacks: Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; FDA OK'es Impella 5.0 and Impella LD Circulatory Assist Devices; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV

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    Thursday, September 17, 2009

    SafetyNet Monitoring System Keeps an Eye on Wards of Patients


    Masimo is releasing a new version of the firm's popular SafetyNet™ remote monitoring system. According to the company, the system can provide continuous pulse oximetry readings from up to eighty patients on four separate hospital floors. The technology aims to decrease respiratory-related adverse events in a high risk population, such as post-surgical patients on the general care floor, patients with obstructive sleep apnea, and those who are on narcotic analgesics. Using internal pagers or interfacing with other messaging systems, the central server can notify clinicians if a patient requires prompt attention.

    The Masimo Patient SafetyNet remote monitoring and clinician notification system combines the gold standard performance of Masimo SET® pulse oximetry with optional Oridion Microstream® end tidal CO2-based respiration rate monitoring at the point of care and wireless clinician notification via pager to provide an unmatched level of patient safety on general care floors. The system uses IEEE industry standards for connectivity—allowing for more efficient sharing of data across a hospital's IT platforms and the option of full integration into a hospital's existing IT infrastructure, providing a lower overall cost of ownership and improved financial benefits.

    The new Patient SafetyNet system is already having a big impact on both nurses and post-surgical patients for two hospitals involved in limited market release testing. Marilyn Nemerever, R.N., director of Acute Care at Swedish Medical Center in Seattle, where the new system is being used to monitor patients in three separate post-surgical units at three different hospitals from a single central monitoring station, stated "We love it. ICU beds are in high demand these days and Patient SafetyNet allows us to more closely monitor post-surgical patients in our med-surg units, so we can use our ICU resources more appropriately. Our nurses now have the piece of mind that comes with knowing that Patient SafetyNet is helping watch over their patients if and when they cannot. And our patients are having better outcomes because we can see, as well as respond to changes earlier."

    Clinicians at Dartmouth-Hitchcock Medical Center, who found that Patient SafetyNet reduced rescue activations by 65% and ICU transfers by 48%—while in some patients where ICU transfer was avoided, length of stay was also reduced from 5.8 to 3.6 days with an associated cost of care reduction of 30%, have also embraced the capabilities of the new Patient SafetyNet system. George T. Blike, M.D., Medical Director of Patient Safety at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, stated; "The new system enhancements allow us to see real-time numerics for each patient at a glance, while the ability to monitor more patients on a single server will enable us to deploy the system across more care areas than before to reduce overall costs of implementation."

    Press release: Masimo Launches Enhanced Masimo Patient SafetyNet™ System to Help Hospitals Reduce Preventable Deaths on the General Floor...

    Product brochure: Masimo Patient SafetyNet System...

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    Tuesday, September 15, 2009

    EnSite Velocity Volumetric Electric Heart Mapping System Gets US Ok


    The FDA has granted St. Jude Medical approval to market the EnSite Velocity™ Cardiac Mapping System. This new package lets cardiologists create comprehensive electrophysiological maps of the heart through a simultaneous use of multiple catheters and electrodes. The company claims that the EnSite Velocity™ is specifically designed to decrease fluoroscope exposure by patients and clinicians:

    [T]he system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap(TM) tool and RealReview(TM) function. The OneMap tool enables physicians to create a detailed cardiac model and electrical map together using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time. The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure. This feature gives physicians a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time. The EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.

    The EnSite Velocity System also continues EnSite's longstanding ability to reduce fluoroscopy exposure and is the only mapping system capable of supporting both contact and non-contact mapping, giving the EnSite Velocity System unmatched versatility in its ability to map any arrhythmia.

    Press release: St. Jude Medical Announces FDA Approval of EnSite Velocity Cardiac Mapping System

    Product page: EnSite Velocity Cardiac Mapping System

    Flashbacks: SJM Releases New EnSite Cardiac Mapping System; Cardiac Electrophysiology Goes Robotic and 3D with CoHesion; St. Jude Medical Gets FDA OK for Cardiac Image Integration Software

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    Monday, September 14, 2009

    Under Development: Pneumatic Heart Pump for Minimally Invasive Delivery


    Researchers at the Vienna University of Technology (Technische Universität Wien) have developed a prototype pneumatic ventricular assist pump that is almost small enough to be delivered percutaneously via a catheter. The current model is only about 10 mm wide and 90 mm long, which means that a clinically useful device would have to be half the size. The development of the new device was commissioned by Werner Mohl, a clinical professor of cardiac surgery at TU Vienna.

    “The aim was to avoid the development of heat which is caused by heart pumps that are driven by an electric motor. The heat which is produced is transferred to the blood. Professor Mohl approached us with a request to construct a pump with pneumatic air propulsion which doesn’t have to be cooled”, explains project manager and associate professor Margit Gföhler from the Institute for Engineering Design and Logistics Engineering at the TU Vienna.

    Assistant professor and project colleague Helmut Mad adds: “The heart catheter pump is intended for temporary bridging after an operation or after a heart attack. It is supposed to be used for a maximum of five to ten days. The pump is powered with compressed air via a tube. Of course, the blood which is transported is hermetically separated from the compressed air. The target capacity should be five litres per minute.” With its technical benchmark data, the heart catheter pump is a very challenging activity from a construction point of view. Gföhler: “Given its size, it is difficult to obtain purchased parts and storage” Special manufacturing and production processes which can be very expensive are required."

    A second prototype has now been produced from a ceramic in collaboration with the Institute of Materials Science and Technology of the TU Vienna.

    Technische Universität Wien press statement: Heart pump with air propulsion...

    Video below the fold demonstrating the pump in action:

    READ MORE...


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    Mayo Clinic Utilizes Neural Networks to Diagnose Endocarditis

    In a presentation to the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), that sounds eerily similar to some of our sci-fi essay contest submissions, researchers from the Mayo Clinic described a new method they are developing to help diagnose endocarditis. The researchers utilized neural networks to analyze clinical data and determine whether or not patients had endocarditis. If the patient had a low probability of infection he/she would not require any further testing, avoiding costly trans-esophageal ultrasounds.

    Here is more information from the press release:

    Endocarditis — an infection involving the valves and sometimes chambers of the heart — can be a problem in patients with implanted medical devices. It is serious and can be deadly. The mortality rate can be as high as one in five, even with aggressive treatment and removal of the device. With additional complications, the mortality could be over 60 percent. Diagnosis usually requires transesophageal echocardiography, an invasive procedure that also has risks. It involves use of an endoscope and insertion of a probe down the esophagus.

    The software program is called an "artificial neural network" (ANN) because it mimics the brain's cognitive function and reacts differently to situations depending on its accumulated knowledge. That knowledge or training is provided by researchers, similar to how a person would "train" a computer to play chess, by introducing it to as many situations as possible. In this case, the ANN underwent three separate "trainings" to learn how to evaluate the symptoms it would be considering.

    The team studied 189 Mayo patients with device-related endocarditis diagnosed between 1991 and 2003. The ANN was tested retrospectively on the data from these cases. When tested on cases with known diagnosis of endocarditis, the best-trained ANN was correct most of the time (72 of 73 implant-related infections and 12 of 13 endocarditis cases) with a confidence level greater than 99 percent.

    Read the press release here...

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    Tuesday, September 8, 2009

    ECG Necklace for Continuous Cardiac Monitoring


    Last week at the IEEE Engineering in Medicine & Biology Conference in Minneapolis, Minnesota, IMEC unveiled a new prototype cardiac monitoring system. Just like a portable Holter monitor, this new ECG necklace is meant to provide long term ambulatory readings to get a full picture of a patient's cardiac electrophysiological health, all while running on a set of batteries for up to seven days.

    It contains IMEC’s proprietary ultra-low power analog readout ASIC (application-specific integrated circuit), and relies on a low power commercial radio/microprocessor platform. A wavelet-based heart beat detection algorithm is embedded in the processor that ensures the accurate computation of the instantaneous heart rate, even under high level of noise. A second ultra-low power microcontroller unit controls the wireless transmission of the ECG data to a computer within a range of 10m. An optional memory module enables data logging for applications in which the receiving computer is not in the neighborhood.

    Ambulatory cardiac monitoring systems today suffer from inaccurate measurements due to artefacts which are inherent to ambulatory situations. IMEC’s embedded beat detection algorithm has been optimized for robust heart beat detection. It copes with baseline wander, EMG (electromyogram) and motion artefacts, and high and variable electrode impedance. Heart beat is detected with 1 sample resolution. The algorithm achieves best-in-class performances, with 99.8% sensitivity and 99.77% positive predictivity on both the MIT-BIH database and a proprietary database of ambulatory ECG recordings. A satisfactory performance is achieved until 0dB SNR (signal to noise ratio).

    Press release: Necklace for long-term and robust cardiac monitoring in daily life...

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    » The Fidelity 100 ECG System (March 30, 2006)

    » Vevo 770™ Micro-imaging System (March 21, 2006)

    » Angio-Seal: A VIP in Cardiac Cath (March 20, 2006)

    » AUDICOR Correlated Audioelectric Cardiography (March 17, 2006)

    » PFX™ Closure System (March 17, 2006)

    » Guidant Documents Reveal Dysrhythmia (February 28, 2006)

    » Murmurs of a Stethoscope Resurgence (February 28, 2006)

    » Olympic Short Track Speedskaters Examined by Ultraportable Ultrasounds (February 17, 2006)

    » In the Works: Collapsible Heart Valve for Children (February 16, 2006)

    » Detecting Cardiac Damage: from 24 hours to 20 seconds (February 14, 2006)

    » Optimizer™ III: Cardiac Contractility Modulation Therapy for CHF (January 31, 2006)

    » HearTwave® II Microvolt T-Wave Alternans System (January 27, 2006)

    » CardiArc: Nuclear Imaging in the ER (January 26, 2006)

    » The Hydron Implant Technology (January 20, 2006)

    » Guidant Madness! (January 19, 2006)

    » Laughter Can Cure (January 19, 2006)

    » DIY Electrocardiograph Kit (January 18, 2006)

    » Cardiac Arrests on Ice (January 9, 2006)

    » Ultrafiltration May Be Practical Alternative to Diuretics (December 9, 2005)

    » D-SPECT™ Cardiac Scanner (December 7, 2005)

    » Discovery VCT -- The World's First Volumetric PET/CT System (December 1, 2005)

    » The Terason t3000™ Ultrasound System (December 1, 2005)

    » The SonoSite® MicroMaxx™ (November 29, 2005)

    » Somatom Definition: The First Dual Source CT (November 21, 2005)

    » Alagebrium to Arteries: Loosen Up (November 21, 2005)

    » LocaLisa® System Lowers Radiation Dose in Peds (November 17, 2005)

    » Dogs Are Truly Man's Best Friend (November 16, 2005)

    » J&J Finally Buys Guidant (November 16, 2005)

    » Womens' Hostility Doesn't Hurt Their Hearts (November 16, 2005)

    » VO2 Max a Good Predictor of Survival Rate for Patients with Coronary Artery Disease (November 15, 2005)

    » Five Heart Beats for LightSpeed VCT (November 15, 2005)

    » EKGuard (November 11, 2005)

    » The EndoSure™ Wireless AAA Pressure Measurement System (November 11, 2005)

    » Ultrasound Cath to Combine 3-D Imaging, Ablative Capability (November 8, 2005)

    » The Ubiquitous Echo (November 7, 2005)

    » HeartPOD™ (November 3, 2005)

    » Victory® Pacemakers (October 28, 2005)

    » HFQRS-ECG (October 13, 2005)

    » Shocking News about Cosmic Rays (October 12, 2005)

    » Stent Wars (September 22, 2005)

    » Flextome Cutting Balloon gets FDA Approval (September 20, 2005)

    » Philips Launches A New Cardiology Ultrasound System (September 15, 2005)

    » IntraVascular MRI (IVMRI) Catheter (August 31, 2005)

    » Lumos DR-T Dual-Chamber ICD with Wireless Home Monitoring (August 30, 2005)

    » Sensation Cardiac 64 (August 9, 2005)

    » Musings on the Philips HeartStart (July 7, 2005)

    » Circulatory System on a Chip (July 5, 2005)

    » Simultaneous Hybrid Procedure for CAD (July 5, 2005)

    » Benephit for Targeted Renal Drug Delivery (June 28, 2005)

    » Guidant Recalls 50,000 Implanted Defibrillators (June 20, 2005)

    » The Sunshine Heart C-Pulse (May 23, 2005)

    » Ready System allows Mini-Bypass (May 19, 2005)

    » Androscope i-stethos Advanced Electronic Stethoscope (May 18, 2005)

    » IntelliVue Telemetry System (May 17, 2005)

    » HyperQ™ (May 16, 2005)

    » Under Construction: 4D Ultrasound System (May 13, 2005)

    » VerifyNow™ Aspirin System (May 11, 2005)

    » Medtronic CareLink® Programmer - Model 2090 (May 5, 2005)

    » AbioCor: It's For a Good Cause (April 25, 2005)

    » The SonoSite® MicroMaxx™ (April 20, 2005)

    » Underground Medgadgets (April 20, 2005)

    » Non-pacing Electric Stimulation for Heart Failure (April 19, 2005)

    » The EKG, Untangled (April 12, 2005)

    » Brilliance 64-slice CT Scanner by Philips (April 4, 2005)

    » Novel Device for High Blood Pressure Implanted (April 1, 2005)

    » Optical Coherence Tomography: Positive Results in Clinical Study Reported (March 31, 2005)

    » TherOx ® AO System for Hyperbaric Oxygen Delivery (March 25, 2005)

    » TriActiv ® Balloon Protected Flush Extraction System (March 22, 2005)

    » Pacemaker study sees increase in heart failure rates (March 15, 2005)

    » Acuson AcuNav 8F for Intracardiac Ultrasound Exams (March 10, 2005)

    » Vasotrac Non-Invasive Blood Pressure Monitor (March 9, 2005)

    » GE's LightSpeed VCT System (March 8, 2005)

    » Endeavor ™ Drug Eluting Stent: Positive Results Reported (March 7, 2005)

    » Biograph 64 PET/CT System (March 4, 2005)

    » DynaCT C-arm System (March 4, 2005)

    » New ultrasound technique reported (March 3, 2005)

    » GuardWire fails in international study (March 2, 2005)

    » UltraStethoscope™ (February 21, 2005)

    » CardioVision MS-2000: predicting a heart attack in the next 10 years? (February 16, 2005)

    » VentrAssist LVAS (February 9, 2005)

    » New procedure for children with LQTS (February 3, 2005)

    » Philos II DR-T from Biotronik (February 2, 2005)

    » INR@Home (January 21, 2005)

    » InSync Sentry: defibrillator and CHF monitor (January 17, 2005)

    » New Linear ™ 7.5 Fr. Intra-Aortic Balloon (January 11, 2005)

    » Signals From Deep Inside (December 28, 2004)

    » The LifeVest Conspiracy (December 28, 2004)

    » ReadMyHeart ECG (December 17, 2004)

    » Personal Health Status Monitor (December 16, 2004)

    » BioZ Dx (December 15, 2004)

    » Q-Stress® version 3.5 (December 14, 2004)

    » Endo-PAT2000 System (December 14, 2004)

    » T-Line Tensymeter (December 11, 2004)

    » iE33 by Philips (December 11, 2004)

    » Vivid i (December 11, 2004)

    » Stereotaxis (December 10, 2004)

    » Native TEQ Dynamic Technology for ACUSON Sequoia; 8V3 Transducer (December 10, 2004)

    » Toshiba Aplio xV (December 10, 2004)

    » Titan (December 9, 2004)