Medline, Return on investment sign two deals on traditional wound care and incontinence products

Printed 11 December 2017

Medline continues to be awarded two new contracts with Resource Optimization & Innovation (Return on investment) through ROi’s Pre-Commitment Program.

Medline, a worldwide manufacturer and distributor of medical products with patient-centered solutions, services and expertise over the continuum of care, today announced it’s been awarded two new contracts with Resource Optimization & Innovation (Return on investment) through ROi’s Pre-Commitment Program. The 3-year collaboration will require impact on February. 1, 2018.

ROi’s Pre-Commitment Program is made to generate significant value for Return on investment people through high-quality, clinically validated supplies sourced in the cheapest cost, permitted with the members’ pre-committed purchasing volume. Return on investment serves greater than 250 hospitals and a pair of,800 non-acute facilities over the U.S.

“Our people have tremendous advantages of the Return on investment Pre-Commitment Program,” explains Joshua Sandler, v . p ., group purchasing, Return on investment. “We will work carefully with this supplier partners to supply possibilities such as the Medline contracts for the people.”

With the Medline contracts, Return on investment people will get access to a portfolio of merchandise associated with traditional wound care and incontinence groups, including gauze, bandages, abdominal pads, underpads and briefs.

“Medline is honored to possess been selected like a collaborative work with Return on investment for fundamental wound care and incontinence products.  These contracts will give you the greatest quality products to assist improve patient look after the Return on investment membership. Medline’s and ROi’s aligned goals in driving clinical outcomes, along with Medline’s breadth of top quality products at competitive prices, were the driving forces within the award,” states Dan Johns, v . p ., national accounts, Medline.

Source: Company Pr Release

Koch Disruptive Technologies to guide $150m investment of INSIGHTEC

Printed 15 December 2017

Koch Disruptive Technologies, a subsidiary of Koch Industries, may be the lead investor inside a $150 million Series E funding round for INSIGHTEC, an industrial-stage medical device company revolutionizing surgery with MRI-led focused ultrasound.

An investment, announced Thursday, allows the organization to help commercialize its approved indications, in addition to continue research in areas for example Parkinson’s disease, Alzheimer’s and brain tumors, while using company’s breakthrough technology to provide treatment inside a non-invasive way.

 It can also be the very first investment for Koch Disruptive Technologies because the business group, brought by KDT President Chase Koch, commenced operations in November.

“This investment aligns well using the founding concepts of both Koch Disruptive Technologies and Koch Industries,” stated Koch. “Having a history of driving innovation and improving patient outcomes, INSIGHTEC has itself invested and expanded its abilities to succeed surgical medicine to enhance the and excellence of existence of countless patients.”

“Hospitals all over the world are more and more going after incisionless treatments for his or her patients using our focused ultrasound therapy,” stated Maurice R. Ferré, MD, INSIGHTEC’s Chief executive officer and Chairman from the Board, that has brought multiple transformative medical technology companies throughout his career. “This investment round elevates INSIGHTEC right into a new proper position inside the healthcare industry.”

INSIGHTEC’s Exablate Neuro may be the first focused ultrasound device authorized by the Food and drug administration to deal with essential tremor which has not taken care of immediately medication and lately received the very best Medical Technology award by Prix Galien.

The organization surpassed the fir,000th patient milestone captured, essential tremor people are routinely receiving treatment with focused ultrasound at 40 medical facilities all over the world.

Using more than 20,000 procedures for a variety of clinical applications already performed using its technology, this investment allows INSIGHTEC they are driving further purposes of MR-led ultrasound to deal with Parkinson’s disease, cancer of the prostate, liver cancer and pancreatic cancer. Clinical research using the company’s technologies have already effectively disrupted the bloodstream-brain barrier, which holds the opportunity of targeted drug delivery to deal with Alzheimer’s and brain tumors.

“Transformative ideas know no borders and may originate from anybody, anywhere,” stated Steve Feilmeier, Executive President and CFO, Koch Industries, Corporation. “We’re well-positioned to harness these breakthroughs happening around the world and also to also support generation x of promising entrepreneurs.”

Jefferies LLC, the worldwide investment banking firm, advised INSIGHTEC for that investment round. Existing investors in INSIGHTEC include Elbit Imaging, You are able to Capital, Focus Holdings, GE Healthcare, GEOC, and Meditech Advisors. INSIGHTEC is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Tokyo, japan and Shanghai.

Source: Company Pr Release

Xenco Medical introduces new trauma surgery delivery application

MDBR Staff Author Printed 14 December 2017

Xenco Medical features TraumaGPS, a brand new trauma surgery delivery application with real-time Gps navigation driver tracking for disposable implant systems.

The very first on-demand Android application will enable surgeons and hospital personnel to request and track the emergency delivery of firm’s sterile-packaged spine systems through monitoring the actual-time movement from the deliverer on the mobile map.

Initially, the firm is solely providing the mobile application to several 65 contracted hospitals over the US.

TraumaGPS allows verified users to request an urgent situation delivery of firm’s different spine implant systemsn for example disposable anterior cervical, posterior cervical, pedicle screw and lumbar interbody spine systems.

Whenever a verified salesman accepts the trauma delivery order, the TraumaGPS mobile application will give you the motive force Gps navigation navigation towards the requestor’s hospital while enabling the requestor to look at the driver’s position up until the delivery of Medical implant systems.

Their systems may be used immediately upon arrival in the hospital, because the single-use and composite polymer instrument and implants are combined in a single sterile package.

The disposable implant systems delivered through TraumaGPS application will give you an efficient method of spine procedures like a single-use and composite polymer implant systems.

Xenco Medical founder and Chief executive officer Jason Haider stated: “Allowing hospitals to exactly predict the appearance of emergency deliveries of Xenco Medical’s surgery-ready implant systems, TraumaGPS amplifies the outcome our single-use devices have in speeding up the surgical process and optimizing care.”

Xenco Medical creates a type of disposable and sterile-packaged spine systems to be used in spine surgeries.


Image: Xenco has launched first on-demand trauma surgery delivery application with real-time Gps navigation driver tracking for disposable implant systems. Photo: thanks to Business Wire.

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

US House provides extend suspension of medical device excise tax

MDBR Staff Author Printed 13 December 2017

The United States House of Representatives Erik Paulsen and Jackie Walorski have introduced H.R. 4716, a brand new legislation that will suspend the medical device tax for 5 years.

The legislation suspends until December 2022 the task and innovation destroying 2.3% medical device excise tax enforced on medical device companies originally set up as area of the Affordable Care Act.

In 2015, a bipartisan coalition in the home and Senate came together to approve a 2-year suspension from the tax, which is due to expire in the finish of the year.

Based on Advanced Medical Technology Association (AdvaMed), the 5-year suspension will give you medical technology innovators with full confidence this tax won’t return into effect.

AdvaMed also claimed that medtech companies can reinvest millions throughout the current suspension, which enables to produce new jobs, capital enhancements and R&D with the development of next-gen technologies for patients.

AdvaMed President and Chief executive officer Scott Whitaker stated: “We are dedicated to ongoing this reinvestment in innovation when the tax is suspended on the lengthy-term basis moving forward.”

“However, basically we applaud this suggested five-year suspension, it’s a merely a foundation the best goal to completely repeal the medical device tax and release the entire commitment of job growth and medical innovation for American patients.”

The Medical Imaging & Technology Alliance (MITA) executive director Patrick Hope stated: “Allowing the unit tax to restart in 2018, even temporarily, would add up to a tax hike around the industry and could cause job loss in addition to disruptions towards the medical imaging industry’s capability to innovate.

“Ultimately, hopefully that Congress will work toward full repeal from the medical device tax to guard high-having to pay, high-quality industry jobs and be sure that patients have the latest medical imaging technology.”


Image: The United States House of Representatives extended the suspension on medical device tax. Photo: thanks to anankkml / FreeDigitalPhotos.internet.

THINK Surgical receives CE mark for that TSolution One surgical system for total knee arthroplasty

Printed 13 December 2017

THINK Surgical has gotten CE Mark approval for that TSolution One surgical system, getting active automatic precision to Total Knee Arthroplasty (TKA).

The TSolution One Surgical System first joined the ecu market in 2015 if this received CE Mark approval for Total Hip Arthroplasty (THA).

Presently, the machine has 510(k) clearance for THA within the U . s . States and 4 centers are enrolling patients to have an IDE clinical study for TKA. Earlier around, the TSolution One Surgical System received Korean-Food and drug administration clearance for THA and TKA. It also received approval for purchase in Israel through the Secretary of state for Health for THA.

“We’re very happy to offer probably the most advanced technologies as a whole Knee Substitute with the TSolution One Surgical System towards the European market along with other countries that depend around the CE Mark,” stated John Hahn, Chief executive officer of THINK Surgical, Corporation.

  “Acquiring the CE Mark represents a vital milestone towards ongoing the worldwide commercialization in our differentiated automatic technology and our dedication to improving patients’ lives and partnering with surgeons to change memory foam surgery.”

TSolution The first is a automatic system that allows surgeons to produce a person’s personalized pre-surgical joint substitute plan, using CT-based 3D planning and also the system’s open implant library to attain an enhanced surgical plan.

During surgery, the robot precisely executes a person’s individual surgical plan by removing diseased bone and preparing the bone cavity and joint surface with sub-millimeter dimensional precision.1 

THINK’s active automatic technologies have been proven to enhance joint substitute implant fit and alignment when compared with conventional joint substitute surgery.2 Accurate implant fit and alignment may result in reduced postoperative discomfort, complications, and improved patient function.3,4

Source: Company Pr Release

Food and drug administration approves Boston Scientific’s Vercise deep brain stimulation system

MDBR Staff Author Printed 12 December 2017

Boston Scientific has guaranteed approval in the US Fda (Food and drug administration) because of its Vercise deep brain stimulation (DBS) system.

DBS is going to be used to treat Parkinson’s disease (PD) signs and symptoms. The condition is really a degenerative condition that affects more than one million people in america and ten million around the world.

The FDA approved the machine in line with the Smart study, that is claimed is the first first multi-center, prospective, double-blind and randomized sham-controlled trial of DBS for PD in america.

The trial assessed the security and effectiveness from the system in 292 patients at 23 sites.

Based on the organization, the research achieved its primary endpoint of mean alternation in waking hrs with higher symptom control.

Your application seemed to be based on safety data in the European multi-center, prospective and single-arm Vantage study.

This Year, the organization first introduced the Vercise system, that was developed according to cochlear implant technology.

Lately, the organization launched new programming software known as Neural Navigator 2 to assist physicians visualizing the stimulation field while configuring DBS programs for patients.

Boston Scientific neuromodulation senior v . p . and president Maulik Nanavaty stated: “This approval marks an essential step for patients who’ll are in possession of careful analysis be given probably the most innovative neuromodulation technologies currently available.

“Our system stands in addition to the field in the approach and it is altering the standard definition about how we are able to leverage technology to deal with patients with Parkinson’s disease.”


Image: Boston Scientific’s corporate headquarters in Marlborough, Massachusetts. Photo: thanks to Boston Scientific Corporation.

Intersect Ing will get Food and drug administration approval for SINUVA sinus implant

Printed 12 December 2017

Intersect Ing has gotten approval in the US Fda (Food and drug administration) for that SINUVA (mometasone furoate) Sinus Implant, a brand new targeted method of treating recurrent nasal polyp disease in patients who’ve had previous ethmoid sinus surgery.

Placed throughout a routine physician appointment, SINUVA expands in to the sinus cavity and delivers an anti-inflammatory steroid straight to the website of polyp disease for 3 months.

Is a result of a randomized medical trial shown a 63% relative decrease in bilateral polyp grade (a measurement from the extent of ethmoid polyp disease) for patients given SINUVA, when compared with control.

“SINUVA represents a significantly-needed breakthrough for that many nasal polyp sufferers that need very effective treatments,” stated Robert C. Kern, M.D., Chairman of Otolaryngology – Mind and Neck Surgery at Northwestern College Feinberg Med school, who offered as national co-principal investigator from the pivotal study from the implant.

“For many patients battling to handle this ailment, the present treatment approaches of repeat surgeries and-dose dental steroids have significant limitations, and intranasal sprays and rinses depend heavily on patient compliance. I expect to offering SINUVA to my patients.”

Nasal polyps are inflammatory growths across the lining of nasal passages or sinuses that induce nasal congestion, infections and lack of olfaction. Lots of people with chronic sinus problems and nasal polyps go back to their Ing specialist with signs and symptoms inside the newbie following initial treatment. Roughly 635,000 Americans have experienced previous sinus surgery and then see their Ing physicians to treat recurring signs and symptoms.

“For greater than a decade Intersect Ing has concentrated on developing innovative therapies for chronic sinus problems sufferers. We’re pleased the approval of SINUVA can give patients with recurrent nasal polyps a brand new option,” stated Lisa Earnhardt, president and Chief executive officer of Intersect Ing.

“This Food and drug administration approval – our 4th commercial product, and our first product to become controlled like a pharmaceutical – is definitely an exciting milestone for the team. We expect to presenting SINUVA to physicians across the nation within the coming several weeks once we work toward our second-quarter launch.”

The Food and drug administration submission for that SINUVA Implant was based on the outcomes of studies of 400 patients, such as the landmark RESOLVE II pivotal study. RESOLVE II met its co-primary effectiveness endpoints, which incorporated a statistically significant reduction from baseline in bilateral polyp grade (p=.007) along with a reduction from baseline Nasal Obstruction/Congestion score (p=.007).

Secondary endpoints achieving record significance through day 90 range from the proportion of patients still indicated for repeat sinus surgery and enhancements in olfaction, feeling of nasal congestion and percent ethmoid sinus obstruction.

Source: Company Pr Release

Medline, Return on investment sign two new contracts on traditional wound care and incontinence products

Printed 11 December 2017

Medline, a worldwide manufacturer and distributor of medical products with patient-centered solutions continues to be awarded two new contracts with Resource Optimization & Innovation (Return on investment) through ROi’s Pre-Commitment Program.

The 3-year collaboration will require impact on February. 1, 2018.

ROi’s Pre-Commitment Program is made to generate significant value for Return on investment people through high-quality, clinically validated supplies sourced in the cheapest cost, permitted with the members’ pre-committed purchasing volume.

 ROi serves greater than 250 hospitals and a pair of,800 non-acute facilities over the U.S.

“Our people have tremendous advantages of the Return on investment Pre-Commitment Program,” explains Joshua Sandler, v . p ., group purchasing, Return on investment. “We will work carefully with this supplier partners to supply possibilities such as the Medline contracts for the people.”

With the Medline contracts, Return on investment people will get access to a portfolio of merchandise associated with traditional wound care and incontinence groups, including gauze, bandages, abdominal pads, underpads and briefs.

“Medline is honored to possess been selected like a collaborative work with Return on investment for fundamental wound care and incontinence products. These contracts will give you the greatest quality products to assist improve patient look after the Return on investment membership.

“Medline’s and ROi’s aligned goals in driving clinical outcomes, along with Medline’s breadth of top quality products at competitive prices, were the driving forces within the award,” states Dan Johns, v . p ., national accounts, Medline.

Medline is really a global manufacturer and distributor serving the medical industry with medical supplies and clinical solutions which help customers achieve both clinical and financial success.

Headquartered in Northfield, Ill., the organization offers 350,000+ medical devices and support services through greater than 1,400 network marketing representatives who’re dedicated points of contact for purchasers over the continuum of care.

Source: Company Pr Release

Stryker to purchase US firm Entellus Medical for $662m

MDBR Staff Author Printed 11 December 2017

Stryker has signed a contract to get US medical technology firm Entellus Medical for approximately $662m.

Their Ing product portfolio includes XprESS multi-sinus dilation system, Latera absorbable nasal implant, MiniFESS surgical instruments, XeroGel nasal dressing and FocESS imaging and navigation solutions.

In This summer this season, Entellus Medical decided to acquire US Ing medical technology firm Spirox for approximately $81m.

Located in Redwood Town of California, Spirox develops, produces, and markets Latera absorbable nasal implant, that is an invasive choice for ENTs and facial cosmetic surgeons to deal with nasal airway obstruction.

Stryker MedSurg and Neurotechnology group president Timothy Scannell stated: “Entellus is really a leader within the Ing segment while offering an extensive portfolio of merchandise which allow physicians to easily and easily execute a wide range of Ing procedures.”

Entellus Chief executive officer Robert White-colored stated: “The mixture of Stryker’s established dedication to making healthcare better and Entellus’ innovative products inside the Ing segment continuously provide our customers the various tools they require for economical solutions.”

In September 2016, Stryker acquired US-based memory foam device company Ivy Sports Medicine to have an undisclosed sum.

Ivy Sports Prescription medication is involved in the event, manufacturing and marketing of tissue growth and repair products that concentrate on upkeep from the meniscus.

Stryker provides services and products in various specialties, including orthopaedics, medical and surgical, and neurotechnology and spine.


Image: Stryker to get medical technology firm Entellus Medical. Photo: thanks to adamr / FreeDigitalPhotos.internet.