An upswing from the hybrid operating room

Recent advancements in heart valves and non-invasive surgery technology have led the way for more patients to be eligible for a endovascular/interventional procedures.  Yet these patients usual to very complex health conditions and therefore are at a bad risk for poor outcomes. In order to improve these poor outcomes and accommodate surgeon and interventionist needs, many hospitals have implemented hybrid operating rooms (typically an OR having a fixed C-arm angiographic system), and much more are thinking about it.

Hybrid ORs include steep cost tags—some could cost greater than $two million. Add-on another $3 million or even more for that appropriate OR equipment, integration systems, and facility renovation costs, as well as your project may now cost north of $5 million.

Cardiac surgeons clearly have an interest in hybrid ORs. But exactly how can a medical facility make sure that other physicians, their support staff and senior hospital/system leadership will also be involved in the look of the very complex set-up?

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Every effective project begins with an positively engaged foundational team. A hybrid OR project team will include vascular, neurovascular, and cardiothoracic surgeons interventional cardiologists interventional radiologists OR nursing staff cath lab nursing staff and also the radiology technicians from both cath lab and interventional radiology. Participation through the IT team is important, as they’ll be key personnel within the integration of apparatus booms, the system’s table, and also the video monitors. The biomedical engineering department should participate this initial team too — they’ll be the “first responders” whenever there is a technical glitch. Finally, administrative leaders in the surgical, cardiac, and radiology departments have to be aboard as volume projections should be made and Finance needs to be engaged to find out when the cost could be justified.

Managing this large team is challenging because of so many different opinions and interests to think about.  Each clinical niche has somewhat unique needs requiring specific equipment placements.  While room sketches from various suppliers are useful, just the most adept clinical user generally is able to imagine the things they mean for the planned space. The Two-dimensional AutoCAD sketches a designer might develop throughout the planning stages are difficult to interpret if you’re not accustomed to studying them. While 3-dimensional and REVIT models tend to be more helpful compared to 2-D ones, a real live space—or a mock-up—really enables clinicians to know the spatial relationships a lot more clearly.  

Among the best methods to observe how hybrid ORs operate in actual practice would be to visit clinical sites where they’re presently installed and talk to frontline staff regarding their specific challenges. Ask users the way they altered the room’s configuration when new clinical services started while using room. Explore the way they manage consumable supplies where they’re stored. Where are their video monitors placed? What are the limitations because of the size the area? Did they select a floor-mounted or perhaps a ceiling-mounted C-arm? Why? Ask why they selected their unique angiographic system and just how they coordinated the different installation efforts. Additionally to any or all your fact-finding, you have to keep the Chief executive officer, COO, along with other leadership up-to-date together with your progress. This generally is one of the biggest capital expenses of the season, as well as in some hospitals it might be the biggest from the decade.

In the end the very fact-finding and installation challenges, your hybrid Or perhaps is almost ready. Before it’s fully operational, conduct some role-playing exercises to make sure that staff are very well experienced in how things works prior to the very first official hybrid procedure. You might want OR staff to look at a cath procedure as well as for cath lab staff to look at an OR procedure. Slight variations – or really major differences—in practice can make cause a lot of confusion when staff expectations are included a hybrid OR.  Make sure credentialing and quality criteria have established yourself.  

When the hybrid Or perhaps is finally under way, monitor surgeon and interventionalist usage—monitor “actual” versus “projected” in the amount of procedures to make sure that goals are met.  

With the right planning, a hybrid OR benefits both patients as well as your hospital’s performance. You might be so effective you need to start throughout again—with planning for a second hybrid OR.

Photo: Simonkr, Getty Images 

Ultrasound Identifies Hands Gestures, Can lead to Hands-free Charge of Surgical Systems


In the College of Bristol within the U.K., scientific study has were able to use ultrasound to identify the hands gestures that an individual is displaying. While there are lots of consumer applying we’ve got the technology, for example gaming and controlling devices throughout the house, this latest “physiologic” way may finish up getting used by surgeons to browse hands-free through radiological images during procedures. It will help to keep sterility while staying away from getting to possess another clinician control the imaging device’s interface. Exactly the same approach might also result in a time while in-clinic touchscreens, which presently assistance to spread infections, may not be necessary. We are able to also picture fraxel treatments getting used for rehab of patients who get over stroke or musculoskeletal disease.

They used a standard ultrasound probe to image your muscle mass from the forearm while different gestures were performed. The investigators then refurbished computer vision and machine learning tools to correlate muscle movements towards the hands gestures they produce. Working backwards, the machine could identify which gestures were created when different muscle motions were detected. Furthermore, we’ve got the technology demonstrated itself even if your muscle motion was detected in the wrist, the place where smartwatches for the future which contain ultrasound transducers will reside.

Check out this demo video revealing we’ve got the technology:

Flashbacks: Gestureplex Wrist Controller for Hands-free Operation of Devices in Surgical Theater… Microsoft’s Kinect Technology Useful for Vascular Surgery… Robotic Assistant Provides a Helping Hands within the OR… New System for Hands-Free Charge of Image Viewer During Surgery… Controlling Augmented Reality within the Operating Room… Real-Time Touch-Free Gesture Control System for Image Browsing within the OR… Low Cost Glove Translates Sign Language, Enables you to Practice Surgery in Virtual Reality…

Paper presented at Proceedings from the 2017 CHI Conference on Human Factors in Computing Systems: EchoFlex: Hands Gesture Recognition using Ultrasound Imaging…

Via: College of Bristol…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

EchoPixel Lets Surgeons See CT, MRI, and Ultrasound Scans in 3D

Because the invention from the X-ray machine in 1895, medical imaging technologies have improved dramatically, however the visualization of individuals images hasn’t altered enough to maintain. Despite the fact that CTs and MRIs capture 3D data, the intake of that data by physicians continues to be almost entirely in 2D formats.

EchoPixel, a business located in Mountain View, California, wishes to bridge the space. Their technology utilizes a patient’s CT, MRI, or ultrasound scans to develop a holographic experience that may be manipulated, shared, or saved later on reference. In so doing, it enables medical teams to higher understand clinical problems and also to communicate better.

EchoPixel’s software platform, True 3D, operates on special hardware that includes a monitor, a stylus, and two glasses. Existing CT, MRI, or ultrasound images are loaded to the software, and also the software “pieces” together the look slices right into a 3D replica from the patient’s scanned anatomy. The glasses allow physicians to determine these patient-specific parts of the body emanating in the display, and also the stylus can be used a manipulation tool to consider measurements, slice through and visualize mix sections, or perhaps place in virtual implantable devices to check sizing.

EchoPixel began from Founder and Chief executive officer Sergio Aguirre’s realization that there’s a disparity between your advanced imaging technologies and also the relatively rudimentary method in which individuals images are consumed. “There are 600 million imaging studies done each year, and also over 1 / 2 of individuals are 3D data sets, but they’re still viewed as 2D,” states Aguirre. Despite the fact that radiologists are educated to understand these 2D images, other clinicians might not grasp their meanings quite as well, he states. “It really limits ale hospitals to leverage all that clinically significant information.” Consequently, Aguirre started focusing on EchoPixel and formally incorporated it this year.

Since that time, EchoPixel continues to be adopted by 15 hospitals. We’ve got the technology has been utilized mostly for heart surgeries, particularly for that diagnosis and surgical planning of pediatric hereditary heart defects. It’s also realizing use within interventional radiology procedures, as it can certainly visualize not just large structures, but smaller sized bloodstream vessels too.

Lately, EchoPixel performed a vital role within an operation to split up conjoined twins at Stanford College Clinic. Throughout the planning stages, for instance, the radiology and surgery teams labored carefully together and used EchoPixel’s True 3D-driven holographic encounters his or her common language. “The radiology team loaded the pictures, highlighted some things, after which presented it towards the surgeons,” recalls Aguirre. The Real 3D images permitted these to collaborate and talk through their options more proficiently, solidify an agenda, after which save that arrange for later reference.

EchoPixel ended up being setup inside the operating room itself, to ensure that surgeons could access their saved plan like a guide. For instance, “they required to make certain these were assigning the bowel towards the correct patient… and [that] these were giving the best vessels right patient,” Aguirre explains, plus they walked from the operating table to double-seek advice from their saved 3D plan several occasions.

By utilizing True 3D to create true-to-size, interactive, patient-specific physiological structures within a few moments, EchoPixel enables physicians to collaborate and operate better. “I think there isn’t any reason any physician ought to be searching, in almost 2018, in a 2D image,” states Aguirre. “It’s just absurd in my experience. I believe the technology’s there, the software’s there, and I’m really looking forward to what’s happening.Inches

To find out more, take a look at EchoPixel’s website here.

Medgadget flashbacks: EchoPixel Interactive Radiography Virtual Reality System for Advanced Surgical Planning… EchoPixel Teams with HP to produce Clinical True 3D Viewer… EchoPixel True3D Viewer Puts Patient Data on Interactive Stereoscopic Display…

CryoLife to purchase German firm Jotec for $225m

MDBR Staff Author Printed 11 October 2017

Medical tool and tissue processing company CryoLife has decided to acquire Germany-based Jotec for around $225m.

According to the deal, CryoLife pays 75% in cash, additionally to issuing 25% of their common stock to Jotec shareholders.

Located in Hechingen, Jotec is involved in the event, production and marketing of medical devices for aortic and peripheral vascular disease.

Their product portfolio includes conventional vascular grafts and interventional implants for vascular and cardiac surgery and radiology and cardiology.

Its products include thoracic stent grafts, abdominal stent grafts and peripheral stent grafts, in addition to interventional accessories.

Additionally, Jotec’s surgical portfolio includes ePTFE vascular grafts and polyester grafts.

 The acquisition allows CryoLife to grow its presence within the endovascular surgical market.

Susceptible to customary closing conditions, the offer is anticipated to accomplish later this season.

CryoLife president and Chief executive officer Pat Mackin stated: “Jotec includes a technologically differentiated product portfolio addressing the $2bn global marketplace for stent grafts utilized in endovascular and open repair of aortic illnesses.  

“Their advanced product portfolio has permitted these to acquire a 17% revenue CAGR in the last 5 years, considerably outpacing the development within the overall European market.”

Jotec Chief executive officer Thomas Bogenschütz stated: “CryoLife is ideally positioned to accelerate adoption in our products through its highly complementary and global cardiac and vascular surgery business.”

Located in suburban Atlanta of Georgia, CryoLife produces, processes and distributes medical devices and implantable living tissues utilized in cardiac and vascular surgical treatments.


Image: CryoLife to get Germany-based Jotec. Photo: thanks to adamr / FreeDigitalPhotos.internet.

Remedē Implantable System Food and drug administration Approved to deal with Moderate to Severe Central Anti Snoring

The Food and drug administration grants Respicardia, a business out of Minnetonka, Minnesota, approval introducing its Remedē implantable anti snoring treatment system. The Remedē treats anti snoring by stimulating certainly one of the phrenic nerves that regulates the game from the diaphragm. Individuals with central anti snoring exhibit shallow breaths and/or pauses in breathing that may have a terrible impact on their sleep quality and, actually, their overall cardiovascular health, while increasing their chances for weight problems and diabetes. Poor people charge of the diaphragm such patients is because the mind delivering improper signals. Restoring normal and regular breathing by paying for such poor signals should aid in reducing or alleviate numerous complications that arise from lengthy term anti snoring.

The Remedē system includes an implantable neurostimulator, electrode results in sense phrenic nerve activity and also to stimulate it, along with a computer tablet to program and configure the implant for individual patient needs. People implanted using the system might be confused for pacemaker patients, because the implants look nearly identical. The leads, though, rather of visiting the heart are snaked to enter and become located within bloodstream vessels near to a phrenic nerve (right or left). After that, the implant can identify the electrical signals the brain passes towards the diaphragm to help make the lung area breathe, modifying its very own stimulation to be able to make amends for weak and poorly timed breaths.

Here’s some details, based on the Food and drug administration, concerning the study that brought towards the approval:

The Food and drug administration evaluated data from 141 patients to evaluate the potency of the Remedē System in lessening apnea hypopnea index (AHI), a stride from the frequency and harshness of apnea episodes. Red carpet several weeks, AHI was reduced by 50 % or even more in 51 percent of patients by having an active Remedē System implanted. AHI was reduced by 11 percent in patients with no active Remedē System implanted.

The most typical adverse occasions reported incorporated concomitant device interaction, implant site infection, and swelling and native injury or pocket erosion. The Remedē System shouldn’t be utilized by patients by having an active infection or by patients who are recognized to require magnetic resonance imaging. This product isn’t meant for use within patients with osa, an ailment where the patient tries to breathe, however the upper airway is partly or completely blocked.

Product page: Remedē System…

More from FDA…

LivaNova’s New SenTiva Neurostimulator for Epilepsy Food and drug administration Approved


LivaNova, a United kingdom firm, won Food and drug administration approvals because of its newest vagus nerve stimulation system for the treatment of epilepsy in patients as youthful as 4 years old. The machine, including the SenTiva implantable neurostimulator and also the VNS Therapy Programming system, monitors brain activity and delivers therapy if this believes a seizure might be imminent. During therapy it continues its monitoring routine, growing its stimulation whether it detects its initial attempts unsuccessful to avoid a seizure.

The SenTiva system is the world’s tiniest available responsive stimulator for epilepsy, that makes it suitable for pretty small pediatric patients. Obviously, bigger patients may also benefit, as it will likely be much more comfortable to put on when compared with bigger similar devices.

The implant’s settings are programmed utilizing an application running on the computer tablet along with a special wand can be used to relay these wirelessly in the tablet towards the SenTiva implant. The brand new wand and application will also be backward suitable for already implanted LivaNova legacy VNS devices.

Because the SenTiva system is used, it records patient data which may be clinically helpful, such as the heartbeat and the body position.

A few of the options that come with the brand new system based on LivaNova:

  • Led programming – Advanced technology enables physicians to rapidly and with confidence deliver treatment with one touch.
  • Scheduled programming – Physicians can securely program multiple therapeutic steps during one appointment the generator will progressively and instantly increase therapy without resorting to the individual to go back to the doctor. Scheduled programming can be quite useful, because so many patients with epilepsy aren’t able to drive. This selection might also permit the patient to attain a therapeutic range sooner.
  • Night and day programming – Physicians have unrivaled versatility to personalize therapy when their sufferers require it at specific occasions, night or day.

Here’s a promo video having a youthful patient that taken advantage of LivaNova’s VNS therapy:

Flashbacks: LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI…  AspireHC Vagus Nerve Stimulator Removed in U.S. Market…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Hologic’s SmartCurve Device Helps In Reducing Discomfort During 3D Mammographies


Hologic is releasing a brand new device that can help to create mammographies a little more comfortable for ladies. The SmartCurve breast stabilization system works with Hologic’s Genius 3D Mammography system, something that the Food and drug administration has considered to become better still at discovering lesions than traditional 2D mammography. The organization hopes that the less painful experience can get more women to choose regular screenings, assisting to stop many installments of cancer in early stages.

In developing the SmartCurve, Hologic’s engineering team recognized that point spent while under compression and just how that compression is shipped would be the greatest factors for patient comfort. Time under compression is tough to lessen, but pressure is a lot simpler, so that they built the unit to suit the 3D geography of women’s breast, permitting adjustment, and assisting to alleviate possibility of pinching.

Since the device may affect final picture quality, the Genius 3D Mammography system includes algorithms that make certain to fix any aberrations.

Here’s some data from the recent medical trial evaluating the SmartCurve:

Inside a recent clinical study evaluating the SmartCurve breast stabilization system to traditional flat paddle compression, the SmartCurve system improved security in 93 percent of ladies who reported moderate to severe discomfort with standard compression. Additionally, 95 % of individuals surveyed would recommend facilities which use the machine. (Cruz, A. Improving Patient Security in Mammography. Hologic WordPress-00119 Rev 001 (2017).)

In some unpredicted surprise, here’s the singer Sheryl Crow speaking about her experience and just how she thinks SmartCurve can help women:

Via: Hologic…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Shandong Weigao to purchase Argon Medical Devices for $850m

MDBR Staff Author Printed 26 September 2017

China-based Shandong Weigao Group Medical Polymer has decided to acquire US-based Argon Medical Devices for approximately $850m.

Shandong Weigao has produced a brand new partnership (JV) through its subsidiary Weigao Worldwide for that purchase of Argon.

Weigao Worldwide owns 90% curiosity about the brand new JV, as the remaining 10% stake is a member of Caymans-based company controlled with a private equity finance firm.

With around 1,200 employees around the world, Argon produces a variety of medical devices for interventional radiology, vascular surgery, interventional cardiology and demanding care procedures.

Argon’s product portfolio includes bone and bone marrow biopsy products, endomyocardial biopsy products, soft tissue and organ biopsy products, in addition to transjugular liver biopsy products.

The organization also produces fluid management systems, urology, vascular and vascular access products.

In Feb this season, Argon has completed the divestment of their critical care business to Merit Medical Systems.

The offer also incorporated the purchase of producing facility in Yishun, Singapore and related commercial operations in Europe and Japan.

Argon stated it divested the company to pay attention to the interventional business around the world.

In 2016, Argon acquired three vascular products from Rex Medical, including OptionELITE retrievable vena cava filter, Cleaner rotational thrombectomy system and UltraStream chronic hemodialysis catheter.

The offer incorporated the purchase of connected ip associated with three products, that have been earlier licensed and written by Argon with an exclusive agreement with Rex Medical.


Image: Shandong Weigao to get US-based Argon Medical Devices. Photo: thanks to adamr / FreeDigitalPhotos.internet.

Abbott’s Ellipse ICD and Associated Leads Approved by Food and drug administration for MRI Scans


Abbott won its first Food and drug administration approval for any magnetic resonance-conditional labeling for just one of its implantable cardioverter defibrillators (ICD), the Ellipse. Additionally, Tendril MRI pacing lead, in addition to Durata and Optisure high current leads which are suitable for the Ellipse, will also be approved safe in a MRI machine as lengthy as certain safeguards are taken. This prevents the entire gamut of diagnostic options still open to patients through an Ellipse implant.

The Ellipse, which delivers as much as 36 Joules of one’s, has already been getting used by a large number of patients, as it’s been available on the market for any couple of years. The brand new approval pertains to patients formerly implanted using the Ellipse and compatible leads. Possibly a number of them are now able to get an MRI for a disorder that was formerly hard to identify, like a magnetic resonance scan was unavailable for them.

A few of the options that come with the Ellipse ICD, based on Abbott:

  • DeFT Response™ Technology: Enables physicians to evolve how treatments are delivered through the Ellipse ICD to make sure each patient receives therapy according to their own need. The feature likewise helps ensure effective therapy delivery with no need to deliver a preliminary shock during the time of implant.
  • SecureSense™: Abbott’s SecureSense formula provides an additional degree of protection for patients by supplying proper sensing inside the heart even just in the existence of exterior interference (referred to as “lead noise”) to guard against unnecessary therapy being sent to the individual.
  • DynamicTx™: With Abbott’s DynamicTx formula, physicians can be reassured that their patient’s products are consistently evaluating the health of charge and adapting the road from the electrical impulse to provide appropriate therapy.

Flashbacks: St. Jude’s Ellipse “Physician-Inspired” ICD Will get Eco-friendly Light in Europe… St. Jude Medical’s High Current ICD/CRT-Ds Approved in U.S… St. Jude Will get CE Mark for Ellipse, Assura High Current Cardiac Devices…

Product page: Ellipse ICD…

Via: Abbott…

Editors

At Medgadget, we set of the most recent medical technology news, interview leaders within the field, and file dispatches from medical occasions from around the globe.

Qfix® Launches New Radiotherapy Positioning Technology for that More Precise Management of Cancer Of The Breast

AVONDALE, Pa., Sept. 23, 2017 /PRNewswire/ — Today, Qfix announced the discharge from the first-in-its-class kVue Access 360 G2 and Access Prone G2 positioning devices that advertise to enhance prone cancer of the breast treatment by considerably reducing radiation dose to healthy tissue while improving patient comfort and reproducible positioning.

By permitting breast growth to fall from the chest wall as patients lay face lower, prone positioning can help to eliminate radiation contact with the center and lung area up to 90%.1 Prone positioning will usually increase the uniformity of dose delivery in addition to treatment precision by reduction of respiratory system motion.2

Outdoors style of the kVue Access 360 G2 and Access Prone G2 devices enhances prone cancer of the breast treatment through precise patient positioning and open access for greater versatility in treatment planning. Both devices connect with the couch the surface of the radiotherapy machine and permit gravity to drag the breast from the chest wall, sparing healthy tissue and developing a uniform shape that allows a far more even dose distribution and improved cosmetic outcomes. When compared with other approaches that achieved effective cosmetic outcomes in 60-70% of cases, prone breast treatment with Qfix’s positioning technology led to effective cosmetic outcomes in 80-90% from the cases.1

Qfix’s kVue Access 360 G2 is made to allow cancer of the breast treatment for the right and left breast. That one-of-a-kind positioning solution inserts directly to the couch top. The lack of a standard couch top underneath the insert eliminates scatter and skin dose. The kVue Access 360 G2 includes an expanded supraclavicular grid, which supplies full use of treat the supraclavicular nodes in a single set-up.

The Access Prone G2 system is CT and MR compatible to steer patients seamlessly from simulation through treatment. Foam padding increases patient comfort and removable inserts could be positioned for either right or left breast treatment. These inserts also boast low electron generating technology, minimizing skin dose and redefining the defacto standard for low attenuating devices. The Access Prone G2 is going to be featured within the “Postlumpectomy Breast Irradiation within the Prone Position” course to become presented by Julia White-colored, M.D., FACR, FASTRO, and Tina LaPaglia, B.S.R.T., R.T.(R)(T), throughout the 41st American Society of Radiologic Technologists (ASRT) Radiotherapy Conference, Tuesday, September 26th, from 10:10-11:10 a.m. within the Novice Room in the Manchester Grand Hyatt in North Park, CA. 

The brand new kVue Access 360 G2 and Access Prone G2 devices is going to be displayed with live demonstrations within the Qfix booth #735 throughout the American Society for Radiation Oncology (ASTRO) annual meeting, September 24 – 26, 2017, in the North Park Convention Center.

About Qfix
Qfix (world wide web.Qfix.com) is really a world leader in radiotherapy focused on helping doctors supply the best patient care using the world’s finest positioning devices to boost the prospect of positive patient outcomes. To learn more, visit world wide web.Qfix.com.

SOURCE: Qfix

1. Santos, Isaura. “Cancer Of The Breast Radiotherapy In Prone Position Reduces Toxic Negative Effects.Inch Radiotherapy News (2014). https://radiationtherapynews.com/2014/10/16/breast-cancer-radiation-therapy-prone-position-reduces-toxic-side-effects/

2. Buijsen, Jeroen, et al. “Prone Breast Irradiation for Pendulous Breasts.” Radiotherapy and Oncology: Journal from the European Society for Therapeutic Radiology and Oncology 82.3 (2007): 337-40. Print Croog, Victoria J., et al. “Faster Whole Breast Irradiation with Intensity-Modulated Radiotherapy towards the Prone Breast.” IJROBP 73.1 (2009): 88-93. Print DeWyngaert, J. Keith, et al. “Faster Intensity-Modulated Radiotherapy to Breast in Prone Position: Dosimetric Results.” IJROBP 68.4 (2007): 1251-59. Print.

View original content:http://world wide web.prnewswire.com/news-releases/qfix-launches-new-radiotherapy-positioning-technology-for-the-more-precise-treatment-of-breast-cancer-300524705.html

SOURCE Qfix

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