Medgadget

Continuous Left Atrial Pressure Monitoring Helps With Management, Outcomes in CHF Patients

Tue, 09 Mar 2010 10:58:45 -0800

St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.

The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn't that be neat?

Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.
Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial's primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg). Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.

The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites.

The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.

Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure

Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System ...

Medgadget 2005 flashback: HeartPOD...

VERATHERM Hyperthermic Perfusion System Gets FDA Green Light

Tue, 09 Mar 2010 00:00:01 -0800

ThermalTherapeuticSystems of Pittsburgh, Pennsylvania received FDA regulatory approval to market the VERATHERM Portable Hyperthermic Perfusion System in the US. The portable device provides cardiac perfusionists with the ability to regulate and monitor the temperature, pressure and flow of sterile fluids, such as cardioplegia.

Features from the product page:

Overall Console Dimensions: 12" x 19" x 14.7" [HxWxD]

Weight: 26.4 pounds

Computer: Touch screen controls, stores and manages procedure data

Propulsion: 250-4000mL/min flow range

Temperature Source: Direct thermoelectric

Temperature Set-point: Warms fluid to maximum settable 43°C regardless of liquid or base temperature

Temperature Monitoring: Built-in direct temperature monitoring

In-line Pressure Monitoring: Built-in direct pressure monitoring

Disposable: Proprietary design with integrated temperature and pressure sensors efficiently delivers sterile fluids

Features: Disposable pressure and temperature sensors are built into the device; telescoping IV pole (37.5" extended height)

Use and Location: Portable and fully functional wherever 115 VAC, 50/60Hz, 15 Amp power is available

Storage: Shelf, storage closet or table-top

Disinfection: Fluid is contained within the disposable set, so that there is no direct console contact with any fluid. This allows for quick and easy disinfection of the console.

Press release: ThermalTherapeutic Systems Announces FDA Clearance of the VERATHERM(TM) Portable Hyperthermic Perfusion System ...

Product page: VERATHERM Portable Hyperthermic Perfusion System ...

(hat tip: MassDevice)

Syncardia's Freedom Mobile Artificial Heart Driver Gets CE Mark

Fri, 05 Mar 2010 11:20:25 -0800

SynCardia of Tucson, AZ, maker of the CardioWest Total Artificial Heart, has received European approval for the Freedom wearable driver. The device allows patients to get off the "Big Blue" driver that powers their heart in the hospital after implantation, and regain a sense of mobility while on wait for a permanent donated organ. It's not clear how long the batteries last before requiring a recharge.

From the announcement:

SynCardia hospital drivers support patients from Total Artificial Heart implant until their condition stabilizes. Once stable, European patients will be switched to the Freedom driver and discharged from the hospital to wait for their matching donor heart at home.

The Freedom driver weighs 13.5 lbs including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia’s older CE approved “proof of concept” portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.

The Freedom driver uses a “dark cockpit” design philosophy for simple and easy operation. Similar to an airplane cockpit, the system only flashes a light or sounds an alarm when something requires the user’s attention.

To make maintenance easier for hospitals, the Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

Press release: Freedom Driver System Receives CE Mark to Power SynCardia's Total Artificial Heart in Europe ...

Flashbacks: Medgadget's SynCardia archives...

Images courtesy of syncardia.com.

marLED Surgical Lights from KLS Martin

Fri, 05 Mar 2010 02:29:47 -0800

By perusing through the latest stuff coming out of Germany, we found a little press release from Gebrüder Martin GmbH & Co.KG, also known as KLS Martin Group, that profiled the company's new generation of operating lights, named marLED.

This operating room fixture runs on what the company calls "Second-Generation LEDs" and is designed to minimize formation of shadows and to deliver a cold, bright light. Furthermore, the marLED can be equipped with KLS Martin's surgiCam SD and HD camera systems, for an intraop procedure recording. The camera can be seen in the picture below.

From marLED product page:

In this brand-new product line, high-performance LEDs are used as a basis for effective problem solution even where surgical field illumination is difficult. By using a new overall approach in terms of design as well as lighting technology, it was possible to overcome the limits of existing solutions and set new standards regarding shadow prevention and color fidelity. The radically new optical and housing concept also makes a lasting contribution towards facilitating the surgeon's work. The innovative, modern design with its symbiosis of ergonomics and technology gives the operating room a pleasing, state-of-the-art atmosphere.

Maximum adaptation of the light field

Space-saving design creates room for movement

Compatibility with laminar flow systems

Ergonomic and perfectly easy operation with sensoTouch and sensoGrip

Cool light and excellent shadow compensation

Variable color temperature

Product pages: marLED; surgiCam

Press release: The marLED Lights from KLS Martin ...

SJM's Aortic Trifecta Valve Gets European Clearance

Wed, 03 Mar 2010 15:24:14 -0800

St. Jude Medical's new pericardial aortic stented tissue valve, the Trifecta, has been granted CE Mark of approval by the European authorities.

Some details about the implant:

The next-generation tissue valve has a tri-leaflet stented pericardial design which offers excellent hemodynamic performance, or nearly unobstructed blood flow, in order to mimic as closely as possible the flow of a natural, healthy heart. The unique valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve.

The valve's titanium stent, which provides a fatigue resistant frame to support the valve within a patient's heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration. Additional attributes contributing to the Trifecta valve's durability include proprietary tissue fixation and St. Jude Medical's patented Linx(TM) AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening).

"The Trifecta valve's superior hemodynamic performance helps to make it very attractive for aortic valve replacement, especially in a small aortic annulus," said Professor Volkmar Falk, Chair of the Division of Cardiac and Vascular Surgery at University Hospital Zurich. "The construction and design of the Trifecta valve allows it to work seamlessly with the patient's heart to generate adequate blood flow, which can offer patients an improved quality of life."

Press release: St. Jude Medical Receives CE Mark Approval for Trifecta Valve ...

RoSS Simulator Preps Surgeons to Use da Vinci Robot

Fri, 26 Feb 2010 00:45:25 -0800

Researchers from Roswell Park Cancer Institute and State University of New York at Buffalo, developed a surgical simulator to help train physicians to operate the da Vinci robot. The RoSS Robotic Surgical Simulator has been turned into a product and commercialized by a spinoff called Simulated Surgical Systems of Williamsville, NY. Practicing physicians and students can train on common tasks like suturing and knot tying, and even perform complete procedures like radical prostatectomies and hysterectomies.

Features of the device:

Stand-alone surgical simulator that is independent of a surgical robot, vision cart

Cost of operating the RoSS is minimal as no consumables or disposables are required

The RoSS data management system allows performance analysis and measurement tools to objectively measure and record performance

User does not require monitoring thus enabling maximum flexibility and opportunity for training

Surgical procedures can be rehearsed

New surgical procedure modules can be added to the RoSS

RoSS does not require an operating room environment and can be set up in a location most advantageous to access and training needs

RoSS has a monitor which allows a user or tutor to observe the procedure

Comprehensive curriculum to train for motor, and cognitive skills required to operate surgical robot

Suite of simulated surgical procedures for fellow or resident to follow, and recreate the surgical steps of an expert surgeon

Press release: Introducing RoSS, a "Flight Simulator" for Robotic Surgery ...

Product page: RoSS Robotic Surgical Simulator ...

Sorin's C5 CPB Machine Gets Green Light in US

Thu, 25 Feb 2010 00:52:06 -0800

Milan, Italy based Sorin Group has received FDA approval for the firm's S5 Heart-Lung Machine. In its press release, the company touts C5 as a highly advanced "lighter in weight and more compact" system that has "excellent manoeuvrability and a well thought-out, logical structure, functional ergonomic design and reliable safety systems. Its solid, brushed stainless steel housing reflects the product's high quality." The cardio-pulmonary bypass (CPB) system has already earned European CE Mark of approval last year.

Add'l features:

Console for 3 to 5 roller pumps

2 additional roller pumps can be mounted on the mast

Panel with 3, 4 or 6 display modules

Flexible mast system

Pump heads can be rotated into position to optimize tubing layout

Two vertically and one horizontally moveable masts for mounting external devices and disposables

Up to four TFT displays can be stacked vertically in the mast panel and each can be configured according to your required perfusion parameters

The brushless, direct-drive motor of the roller pumps reduces noise and vibration, making S5 one of the quietest systems of its kind

The footprint of the S5 has been reduced by 20% and overall weight has been reduced by 10%

System panel can be easily mounted and adjusted both horizontally and vertically

High resolution TFT displays enable the perfusionist to easily view displayed values from greater distances and at an angle of up to 140 degrees

Full text messages for alarms and warnings

One key each for muting, clearing and overriding alarms

Differentiated alarm tones

Quick and easy replacement of all DCMs

UPS can bridge a power failure up to 130 minutes (20 minutes at full load)

Speed adjustments are performed via an Incremental Encoder, a maintenance-free technology that increases longevity and reliability

Clearly structured, intuitive and descriptive menu system eliminates guesswork, and one-touch accessibility improves user convenience

Miniaturized sensor modules utilize 100% SMD technology

Operated by PC-independent software using state-of-the-art microcontrollers in conjunction with a high-integrity serial CAN bus

No boot time required after power-up—the system is ready for operation within 3 seconds

Product page: S5 HLM...

Press release: SORIN GROUP ANNOUNCES U.S. FDA CLEARANCE OF NEWEST GENERATION HEART LUNG-MACHINE (.pdf)...

GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide

Tue, 16 Feb 2010 00:56:00 -0800

GE Healthcare is finally releasing the much awaited Vscan pocket sized ultrasound. Many in the industry hope that this device offers a chance for physicians to make a move from stethoscopes to portable imaging devices, bringing advanced visualization to any examination room. The unit weighs one pound and is only 3 inches (7.6 cm) wide and 5.3 inches (13.5 cm) long, offering both standard black and white imaging, as well as colored blood flow doppler. GE is touting Vscan's size and capabilities for cardiologists to transthoracically view myocardium, pericardium, and heart valves, and for primary care physicians, as well as OB, ER, and others, to scan the liver, kidney, aorta and peripheral vessels, babies in the womb, and anything else the transducer can penetrate.

Features from the product FAQ:

An online portal provides Vscan users with training tools for the product and basic clinical
applications with sections about imaging technique, anatomy and trouble shooting

Intuitive user interface that can be controlled using the thumb

Intelligent workflow enhancements

Battery charger station and battery life of one hour scanning - good for up to 30 patients based on
average of 2 minutes per scan

Voice annotation

USB docking station

Link to a PC for organization and export of data

Gateway software with services tools and remote diagnostics

Here's our video from a GE event introducing the Vscan:

Press release: GE Healthcare Introduces Vscan™ Pocket-sized Visualization Tool for Point-of-care Imaging

Product page: Vscan ...

Flashbacks: A Closer Look at GE's Vscan Pocket Ultrasound ; More Details About The New GE Vscan Ultrasound System; GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope

FDA Approves World's Most Powerful Cardiac Resynchronization Therapy Defibrillator

Thu, 11 Feb 2010 09:39:12 -0800

Sorin Group (Milan, Italy) has announced U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym CRT Model 8750. According to the company, this is the world's most powerful AICD, with a 37 Joule punch:

Paradym™ offers consistent charge times throughout the life of the device (10s at Beginning Of Life, 13s at Elective Replacement Indicator - ERI), improved longevity, and a 6-month ERI to End of Service (EOS) period, twice as long as any other ICD.
Paradym™ CRT is designed to allow more flexibility in the management of cardiac resynchronization and antitachyarrhythmia therapy in heart failure patients. BTO (Brady-Tachy Overlap) is designed to unlock pacing and detection to ensure delivery of resynchronization therapy at high pacing rates during exercise without any compromise on the management of slow ventricular tachycardias (VTs). BTO gives freedom of programming for physicians.

Paradym™ CRT, at 34cc and 11mm thin, also features the PARAD®+ detection algorithm whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage recorded thus far.

Press release: SORIN GROUP ANNOUNCES MARKET RELEASE AND FIRST IMPLANT OF NEXTGENERATION CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR...

Product page: PARADYMTM CRT 8750 ...

St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices

Fri, 05 Feb 2010 11:45:10 -0800

St. Jude Medical has received the European CE Mark of approval for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator. The devices are smaller and can deliver a stronger punch than previous generation models, and they feature new heart monitoring algorithms.

These devices feature 40J of delivered energy (45J stored) - the highest energy level available in the industry - helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.
Because of the devices' narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company's SJ4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient's chest.

The Unify CRT-D and Fortify ICD also incorporate the new CorVue(TM) pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient's heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.

Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.

In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.

Press release: St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors