Medgadget

Let Draeger Polaris Be Your Guiding Light

Fri, 20 Nov 2009 00:00:01 -0800

We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.

Details from the press release:

Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.
The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.

This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.

The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.

The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.

Press release: Precision lighting with the new Dräger Polaris...

Product brochure... (.pdf)

My Lab One Portable Ultrasound from Esaote Makes Debut

Thu, 19 Nov 2009 00:46:33 -0800

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...

DermaStream CST for Active Wound Management

Wed, 18 Nov 2009 00:05:44 -0800

Israel21C is reporting that EnzySurge out of Rosh Ha'ayin, Israel is expecting to begin FDA approval process for the complete DermaStream CST system. The wound healing device is designed to be placed over a wound to provide continuous cleaning and washing away of debris and extravasated fluid. Although the device itself received FDA clearance, the bio-active chemical solution that it is supposed to work with it has yet to get a green light.

The patent pending DermaStream CST device provides the mechanism for EnzySurge's proprietary Continuous Streaming Therapy™ (CST). CST is a modality based on continuously streaming of fresh therapeutic solutions to the wound bed while removing exudates by vacuum assisted drainage throughout the treatment cycle. The combination of the DermaStream CSTdesign and the CST action produces negative pressure above the wound without the need for external equipment.

DermaStream is designed to ensure ongoing, uniform flow of fresh solutions over the entire wound bed

The use of therapeutic solutions allows for a broad wound management platform

DermaStreamCST vacuum assisted drainage continuously removes exudate and infectious material from the wound environment.

Gravity-induced negative pressure removes exudates including removal of loose necrotic burden

DermaStream CST is a disposable, single patient use device. It is designed to provide negative pressure above the wound bed without expensive external equipment.

Demo video of the DermaStream CST:

Product page: DermaStream CST ...

More about EnzySurge's technology from Israel21C...

Flashback: DermaStream Chronic Wound Treatment Technology

Merit Laureate Guide Wire Going to Market in US

Mon, 16 Nov 2009 00:00:00 -0800

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 ...

FDA Grants Vascular Solutions Clearance for The GuideLine Catheter

Thu, 12 Nov 2009 00:22:56 -0800

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 ...

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

Mon, 26 Oct 2009 00:54:17 -0800

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

Lap-Pak, a Student Designed Abdominal Retractor, On Road to Market Realization

Fri, 23 Oct 2009 01:44:53 -0800

A device developed by clinicians and students at Johns Hopkins University to move bowels out of the way in laparotomies has been licensed to Seguro Surgical, a Columbia, Maryland company. The Lap-Pak is see-through and flexible, giving you ability to quickly displace the guts without all the towels and sponges and external retractors.

The primary goal for Lap-Pak is to reduce bowel packing time by 50%. Use of Lap-pak during laparotomies ensures interoperability with retractors, facilitates monitoring of bowels, and maintains tissue temperature and hydration.

The Lap-Pak device is a one-piece device constructed from a soft and flexible material that is easy to position. It contains a stable body support that evenly distributes pressure. Side and bottom flaps contour against the abdominal walls to prevent movement and allow for varied cavity sizes. The dual top flaps shield the bowels while maintaining visibility of the intestines as well as internal temperature and moisture. The product will be offered in three sizes designed to fit over 80% of adults.

Press release: Seguro Acquires Worldwide Rights to Johns Hopkins Abdominal Surgery Device...

Product page: Lap-pak...

ThumBlade Scalpel Safety System

Wed, 21 Oct 2009 11:34:10 -0800

Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.

Medgadget has obtained the following details about the device:

Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.

Product page: ThumBlade™ safety scalpel system...

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

Wed, 21 Oct 2009 00:50:51 -0800

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.

Guardian II Hemostasis Valve Gets FDA Nod

Tue, 13 Oct 2009 00:19:41 -0800

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...