PQ Bypass receives IDE approval to initiate study of technique of patients with peripheral artery disease

Printed 14 December 2017

PQ Bypass has gotten conditional approval of their investigational device exemption (IDE) in the US Fda (Food and drug administration) to initiate the pivotal DETOUR II medical trial.

Because the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will assess the safety and effectiveness from the DETOUR System in as much as 292 patients with lower limb ischemia because of lengthy blockages (>15 cm) within the superficial femoral artery (SFA) brought on by peripheral artery disease (PAD).

“Patients with existence-restricting claudication or critical limb ischemia normally have lesions more than 15 cm, so we realize that lesion length is directly proportional to patency. So far, endovascular ways of treating these lengthy lesions haven’t been similar to open bypass surgery,” stated Sean P. Lyden, M.D., professor and chairman from the department of vascular surgery, Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic, and national co-principal investigator of DETOUR II.

“The DETOUR procedure is made to treat patients with seriously calcified or lengthy-segment disease. It’s basically a femoropopliteal bypass with polytetrafluoroethylene, but done percutaneously. The DETOUR I trial in Europe shown safety and effectiveness in patients with lesions as lengthy as 44 centimeters long, so we expect to ongoing to review this process using the commencement of DETOUR II.”

DETOUR II is really a prospective, single-arm, global multi-center trial and will also be conducted at as much as 40 sites to allow the gathering of safety and effectiveness data meant for a pre-market approval (PMA) submission towards the Food and drug administration.

Furthermore, to show health economic outcomes, the trial features a prospective economic study made to collect data associated with the expense connected with treating PAD within the study population. An financial aspects core lab may lead the gathering of quality-of-existence outcome measures (collected at baseline, thirty days, six and 12 several weeks), and procedural and follow-up costs, including rehospitalizations, through 24 several weeks.

“We labored carefully using the Food and drug administration, leading physicians and healthcare managers to create an effort that people be prepared to demonstrate the entire worth of this excellent method of treating severe PAD,” stated Richard Ferrari, chairman from the board of company directors at PQ Bypass. “DETOUR II is definitely an exciting milestone within the journey toward creating a potentially transformative future standard of take care of these patients.”

Percutaneous femoropopliteal bypass (the DETOUR procedure) is definitely an entirely new procedure enabled by PQ Bypass’ proprietary DETOUR System, which is composed of the TORUS Stent Graft, DETOUR Crossing Device, and DETOUR Snare. The DETOUR procedure results in a path that comes from the SFA, travels with the femoral vein and leads to the popliteal artery, bypassing the diseased area of the artery.

This path enables TORUS Stent Grafts to become put into a continuing line and consistently re-direct oxygen-wealthy bloodstream round the blockage, restoring bloodstream flow towards the calf and feet from the patient. Unlike existing technologies for example stents and drug-coated balloons, which just produce a funnel with the disease and aren’t created for very lengthy blockages, the DETOUR procedure is really a unique solution made to supply the reliability of open bypass surgery however with a non-invasive approach.

“The DETOUR System includes a truly innovative, intuitive design and also the trial will investigate its benefits in addressing lengthy lesions that aren’t well offered by existing minimally-invasive approaches,” stated Jihad A. Mustapha, M.D., clinical affiliate professor of drugs, Michigan Condition College College of Osteopathic Medicine and national co-principal investigator from the DETOUR II Trial. “We expect to dealing with the DETOUR II Trial clinical sites about this important research.”

Source: Company Pr Release

Stratasys Releases Type of Custom Made 3D Printed Anatomy Models


Stratasys, among the big 3D printing companies, has announced the discharge of their new BioMimics type of 3D printed human body models. These products are created to be utilized in clinical training and also to help design and test new medical devices.

The organization is first releasing bone and heart models, with vascular structures expected to be shown early the coming year. The models might have simulated disease areas that may further assist in testing new items as well as for training clinicians how you can do delicate surgical treatments. The organization hopes the printed BioMimics models can help alleviate the requirement of animal and cadaver models, and will be offering an simpler-to-use products which may be just like effective oftentimes.

The models can be found like a service, with companies and research institutions ordering the key they need for his or her applications. Stratasys consequently returns multi-material prints that may be both soft and hard, have different feel and textures, which mimic many of the characteristics from the anatomy they’re copying.

“BioMimics is really a revolution in medical modeling, taking advantage of advanced 3D printing approaches for clinically accurate representations of complex human anatomies – from microscopic patterns of tissue to replicating soft to hard texture of body structures,” said Scott Rader, GM of Healthcare Solutions at Stratasys. “Armed with unmatched realism of BioMimics, researchers, educators and manufacturers can finally make use of the tools to demonstrate out new ideas lengthy before numerous studies, and demonstrate innovations towards the skilled physicians who depend in it.Inches

Link: Stratasys homepage…

Via: Stratasys…

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.

High-speed Video Precisely Captures Bloodstream Cell Velocity

Researchers at ITMO College in Saint Petersburg, Russia, allow us a non-invasive high-speed video capillaroscopy system that may precisely appraise the velocity of bloodstream cells flowing through capillaries within the skin around a finger nail. The process might be helpful in assessing cardiovascular conditions.

Capillaroscopy systems provide a easy and non-invasive method to measure the shape and size of capillaries or capillary systems, which could reflect the health of the whole vascular network. Another possibility is calculating the rate of bloodstream cells within the capillaries, which could showcase overall bloodstream flow velocity. This post is helpful in conditions for example diabetes and heart disease.

“Flow velocity is very central in estimating the health of any tissue by its bloodstream supply. For example, in diabetes the circulation speed may alter despite the fact that bloodstream vessels generally seem to be normal,” states Nikita Margariants, among the researchers active in the study.

So far, techniques to measure bloodstream velocity in capillaries haven’t been very accurate or reliable. “There are alternative devices that may only provide a rough average estimate of bloodstream cell velocity,” states Mikhail Volkov, another investigator active in the study.

The study team’s solution involves optical equipment, high-speed video capture, and specifically designed software. When pressed from the skin beside a finger nail, their device can capture high-speed video of red bloodstream cells flowing through capillaries. Then, the program processes the frame sequence to evaluate the form and configuration from the capillaries, combined with the distance the red bloodstream cells travel per unit time. The process enables for very precise velocity measurements.

“Although easy, our device is capable of doing supplying reliable data that may be very helpful for disease pattern recognition,” states Igor Gurov, lead author around the study. “What is much more, this type of diagnostic procedure is completely painless, comfortable and safe for patients.”

“Our primary task now is by using the machine to deal with socially significant illnesses. Particularly, the machine is definitely an effective tool for studying what goes on in bloodstream vessels during heart disease and just how drugs affect bloodstream flow recovery,” states Margariants

Assessment of bloodstream flow velocity. Credit: spiedigitallibrary.org

Study in Optics and Lasers in Engineering: High-speed video capillaroscopy way of imaging and look at moving red bloodstream cells…

Via: ITMO University…

Healcerion Receives Food and drug administration Clearance for brand new SONON 300L Wireless, Application-based Ultrasound System

Healcerion, located in Columbia, was the very first company to get Food and drug administration clearance for his or her wireless, application-based ultrasound system in 2015. The groundbreaking work made by South Korean engineers and scientists laid the building blocks to add mass to an ultrasound transducer that actually works with many smartphones or tablets. Since presenting the SONON 300C convex transducer, the organization continues to be making progress to help advance this branch of ultrasound devices. Their latest, the SONON 300L straight line transducer, weighs only 13 ounces (370 grams) such as the battery, featuring color doppler way of simpler musculoskeletal (MSK), vascular, small parts (breast, thyroid), lung imaging, plus much more.


The SONON series may be used to connect and transmit through Wi-Fi in addition to 3G/LTE, so doctors also have a web connection, even just in many remote regions around the globe. Its size, weight, and abilities, combined with the three hour scan time allow it to be ideal for emergency and everyday use. The Food and drug administration approval for SONON 300L implies that application-based ultrasound is ongoing to maneuver forward. Although it cannot yet replace conventional full-size ultrasound systems, it’s remember this that computers used to consider whole rooms too, however smartphones are more effective than individuals behemoths were in the past.

Healcerion Chief executive officer, Dr. Benjamin Ryu stated, “A doctor from Africa lately told us that whenever imaging a couple month old baby, they found hydrocephalus, fluid buildup within the brain. The physician required a picture she taken with this system and sent it to some neurosurgeon through WhatsApp, who then determined that surgical intervention could be needed to get rid of the fluid. This situation shows the real potential in our system for telemedicine applications and beyond.”

Here’s much more about the SONON device getting used in Africa:

Here’s an instructional video explaining ways to use the device:

Product page: SONON 300L…

Flashback: Healcerion SONON 300C, an Food and drug administration Approved Ultrasound No more than a Transducer…

Food and drug administration Cleares BRH-A2 to deal with Serious Wounds Using Electric Fields and Ultrasound


BRH Medical, a business located in Jerusalem, Israel, won Food and drug administration clearance because of its BRH-A2 system that utilizes ultrasound and electricity to heal deep and chronic wounds. While using two methods enables to hurry in the healing from the wound while reducing discomfort during treatment. Both electric fields and ultrasound energy are delivered into and underneath the wound, treating it all sides. To pay for an array of treatments in a single session, the unit varies the regularity and strength from the electric and ultrasound stimulations. The unit could be in combination with other therapeutic methods, for example negative pressure therapy.

Because most patients receive multiple treatments, the unit features a patient and wound management system for monitoring how situations are progressing with time. It is also accustomed to measure ulcers, including ones with poorly defined edges.

Much more about BRH Medical’s technology, based on its website:

The BRH-A2 device implements a distinctive mixture of therapeutic ultrasound and electrostimulation in modulating cycles of independent and joint activity. Figuring out the very best amounts of stimulation for optimal treatment parameters are caused by countless hrs of scientific experimentation and laboratory simulations.

The BRH-A2 device combines the 2 modalities, and modulates both of them individually as well as in combination throughout the treatment period. Caused by this excellent activity alters the general impact on cellular structures as well as modifies the directions of cellular and subcellular aggregation.

An established aftereffect of ultrasound would be to stimulate fibroblasts to produce bovine collagen, also to lay the brand new bovine collagen inside a more purchased pattern, producing a better weave for epithelialization. Electrostimulation may pull taut the fibroblasts and resultant bovine collagen,  yielding a more powerful weave. The finish consequence of while using two technologies is really a more purchased and tighter bovine collagen weave.

Product page: BRH-A2…

Via: BRH Medical…

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.

Butterfly iQ, an entire body Ultrasound That Matches inside a Pocket


Butterfly Network, a strong located in Guilford, Connecticut, won Food and drug administration clearance and it is presenting its Butterfly iQ portable ultrasound system. It includes a portable transducer that connects straight to an apple iphone, as well as an iOS application to show the pictures and also to control settings.

The unit really works as three different transducers because of an ultra wide band matrix array. This enables a clinician to carry out a couple of different scans but for the Butterfly iQ to become relevant in various clinical settings. The matrix variety of microelectromechanical (MEMS) sensors is directly integrated onto a built-in circuit which contains all of the necessary electronics. This tight integration supposedly produces a fast, high-resolution device that may perform tasks that just full-sized ultrasound machines were capable only a couple of short years back. The firm compares its technology to how photo camera sensors happen to be integrated within smartphones, enabling anybody to possess top quality photo imaging within their pocket.

Possibly the greatest cope with the Butterfly iQ is it costs under $2,000. Previous portable, hands-held ultrasounds have frequently been costing greater than $10,000.

This can be a promo video for that Butterfly iQ:

Listed here are a few videos taken while using new device:

Product page: Butterfly iQ…

Via: Butterfly Network…

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.

Esaote Unveils Its Flagship MyLab9 Ultrasound System


Esaote, an italian man , ultrasound manufacturer, just unveiled its completely new high-finish MyLab9 ultrasound system. The unit is made for a variety of diagnostic imaging procedures and clinical environments. The MyLab9 features non-composite single very probe technology and “Ultra-engine” platform that together generate top quality images in a number of cases from Primary health care provider/GYN to cardio to lesion recognition.

The brand new system includes something known as easyMode, an application feature that instantly optimizes scans with minimal input in the user using a small built-in touchscreen. Esaote’s i-motion technology helps you to produce quality images at high frame rates when imaging moving objects. To best match the primary monitor’s brightness towards the illumination from the room by which a test takes place, a sensor can be used to create automatic adjustments.

So far as the insides, the MyLab9 uses Home windows 10 computer sporting an Apple Core i7 processor along with a solid condition hard disk.

“Today economic constraints, and the rise in average existence expectancy, are opposing forces,” stated Esaote’s Massimo Rosa, Chief Global Marketing Officer. “The MyLab9 eXP provides advanced diagnostic abilities and clinical effectiveness to reply effectively towards the most demanding healthcare needs expanding the use of innovative technologies for additional customers.”

Here’s a good example picture of a fetus taken using the MyLab9:

Product page: MyLab9…P

More from Esaote…

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.

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.

New Microsurgery Robot Helps you to Suture Small Vessels to deal with Lymphedema

At Maastricht UMC+, an instructional hospital within the Netherlands, the very first surgical treatment using a new microrobot continues to be effectively performed. The physicians used a method from Microsure, a Nederlander firm that spun removed from Eindhoven College of Technology and Maastricht UMC+, to suture sub-millimeter vessels within the arm of the patient struggling with lymphedema.

The automatic device converts the movement from the surgeon’s hands into precise, but small actions from the robot, giving physicians an unparalleled degree of skill that might be impossible with only bare hands.

Throughout the surgery, lymphatic vessels which is between .3 and .8 millimeters across were mounted on bloodstream vessels, allowing lymphatic fluid to empty in the area, alleviating painful and harmful swelling.

While this sort of surgery isn’t a break through, along with a couple of surgeons all over the world can carry it out without the assistance of robotics, it remains incredibly difficult. The steadiest of hands still tremble a little and the quantity of focus needed from the physician makes this sort of procedure extremely difficult for many surgeons. The machine basically erases the shaking before transferring the hands movement data towards the robot, maintaining a steadiness that just a robotic can maintain.

“Microsure enables us to be really precise within our movements during procedures that require a surgical microscope,” said Shan Shan Qiu Shoa, cosmetic surgeon at Maastricht UMC+. “Their robot enables us to function on minuscule lymph vessels and bloodstream vessels with increased ease, whilst getting better recent results for these complex and fatiguing interventions. Besides it’s very convenient that, within microsurgery, we are able to work on vessels of each and every size with this particular robot. Most significantly, obviously, this really is great news for that patients concerned.”

Here’s a few videos providing you with phone Microsure automatic system:

Link: Microsure homepage…

Via: Eindhoven College of Technology…

(hat tip: Engadget)

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.