New Technology – Spine Imaging through vibrations

Seismic for the Spine (Orthopedic Design and Technology)
Magnetic resonance image isn’t everything. A new University of Alberta study shows that vibrating the spine may reveal more when it comes to treating back pain. Teaming with the University of South Denmark to study the lumbar spine of twins, Greg Kawchuk and his team demonstrate that structural changes within the spine alter its vibration response significantly.   Instead of using large seismic vibrations to find oil, we used gentle vibrations to find out where problems exist in the back,” explained Kawchuk, professor of physical therapy at the U of A’s Faculty of Rehabilitation Medicine. “By studying and testing vibration responses in identical twins, we were able to demonstrate that structural changes within the spine alter its vibration response.”   Publishing online in Scientific Reports on March 11, 2016, the identical twin study design is significant and unique for biomechanical studies like this one. In the instance where twins had similar spines, the vibration responses were statistically similar. Alternatively, if one twin had a different spine, due to an accident or injury for example, the vibration responses were significantly different from each other.   “In Denmark we have the world’s largest and most comprehensive twin registry and using this unique resource, we have been able to contribute to research that can potentially help to diagnose millions of back pain patients,” said Jan Hartvigsen, professor of clinical biomechanics and musculoskeletal research, University of South Denmark.   The findings show the viability of vibration as a diagnostic tool that could help improve MRI utilization in the short term, Kawchuk said.   “One of the biggest problems in back pain today is over utilization of MRI scans in patients that do not need them. This is a waste of health care resources that leads to over treatment and even increased disability. By using a simple, safe and inexpensive technology like this, we can potentially decrease the use of these scans significantly,” said Hartvigsen.   The study also has implications in the long term and could provide new diagnoses not seen by current imaging tests.   “While an MRI shows us a picture of the spine, it doesn’t show how the spine is working. It’s like taking a picture of a car to see if the car is capable of starting. Vibration diagnostics shows us more than how the spine looks, it shows us how the spine is functioning,” explains Kawchuk.   “Back problems are a significant cause of disability worldwide. For 90 percent of these patients, current diagnostic methods are not able to identify their problems,” said Cameron Schuler, president and CEO, VibeDx, who co-founded the VibeDx Diagnostic Corp, a TEC Edmonton spinoff company that has licensed the technology developed by Kawchuk. “Our hope is VibeDx will help improve our ability to identify the cause of the patient’s back problem, which will then assist clinicians in matching a patient to the best course of treatment for their specific situation.”   “VibeDx is a TEC Edmonton client and we’re delighted to see international recognition for this innovative University of Alberta spinoff,” said Chris Lumb, CEO of TEC Edmonton, an accelerator for early stage technology companies. “VibeDx is a prime example of the outstanding research and commercialization taking place in Edmonton and at the University of Alberta.” – See more at: http://www.odtmag.com/contents/view_breaking-news/2016-03-11/seismic-for-the-spine/#sthash.hhjwova4.dpuf

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DePuy loses $502M in a metal-on-metal hip lawsuit

Defective Hip Lawsuit Funding Firm, Fair Rate Funding, Reports $502 million Verdict in Pinnacle Hip Implant Trial (press release)
Fair Rate Funding, a lawsuit funding firm specializing in the lawsuit cash advance funding of defective hip implants has learned that a Dallas jury awarded a $497.5 million to five plaintiffs severely injured by Pinnacle metal-on-metal hip implants.  The lawsuit was broken down as $142 million compensatory and $360 million punitive damages against Johnson & Johnson (J&J).  The case was tried in the U.S. District Court for the Northern District of Texas.
The trial consolidated five separate plaintiffs asserting that the DePuy hip implants were defective in that they caused metallosis, a condition in which small metal particles enter into the patient’s blood causing severe injuries.
The five cases that were decided: Aoki v. DePuy Orthopedics, et al., No. 3:13-cv-01071-K; Christopher v. DePuy Orthopedics, et al., No. 3:14-cv-01994-K; Greer v. DePuy Orthopedics, et al., No. 3:12-cv-01672-K; Klusmann v. DePuy Orthopedics, et al., No. 3:11-cv-02800-K; and Peterson v. DePuy Orthopedics, et al., No. 3:11-cv-01941-K.
At trial, Plaintiffs’ attorneys produced evidence which suggested that doctors lied in the clinical testing of the implant products and forged other documents designed to misstate the results certain patients experienced when using the product.
“We are pleased with this victory for victims of these dangerous devices,” said Paul Coppola, President of Fair Rate Funding, a lawsuit funding firm which has been helping hip implant defect plaintiffs for years.  “The testimony gives the public the opportunity to hear how major medical products can be approved for use based upon false data and testing.  If true, it shows how J&J prioritizes profit over people.  We hope this outcome will help bring the remainder of the hip implant lawsuits to settlement quickly.”
Since learning of the problems caused by defective hip implants, Fair Rate Funding has worked with thousands of plaintiffs in an effort to secure defective hip lawsuit funding.  These funds are used to help clients pay for ordinary expenses or whatever financial matters arise.  There are absolutely no restrictions on the use of the money and no upfront costs to apply.
By offering cash now to help pay for any type of expense such as car loans, rent and mortgage payments, utility payments, personal loans, and daily living expenses, Fair Rate Funding eases some of the financial stress these plaintiffs endure.  There are no restrictions on the use of the funds.
Fair Rate Funding specializes in advancing cash now for plaintiffs who are involved in personal injury lawsuits including defective hips. Sometimes referred to as settlement loans or lawsuit loans, settlement funding is NOT a loan transaction but a purchase of a portion of a future recovery.  If the lawsuit is unsuccessful for any reason and no money is recovered, the lawsuit funding is not repaid.
Fair Rate Funding works diligently to afford lawsuit funding to its applicants and has representatives standing by 24 hours a day, seven days a week to answer questions regarding the lawsuit funding process.
Fair Rate Funding lawsuit settlement funding programs are not a lawsuit loan or lawsuit loans although they are often referred to as such.  A pre-settlement lawsuit cash advance is not a settlement loan or settlement loans because the advance is only repaid if the case is successful.  Your attorney will repay your case funding or lawsuit advance ONLY if your case is won or settled.
Fair Rate Funding prides itself on providing the quickest approvals – as soon as 24 hours on most cases, the lowest monthly usage rates – as low as 2.5% per month, and the most attentive customer service in the lawsuit funding industry.
Fair Rate Funding also offers free case evaluations.  If you are, at any time, not interested in pursuing lawsuit funding, there are no costs to you and absolutely no obligations.
For more information about lawsuit funding and other services from Fair Rate Funding, simply call a representative at 888-964-2224, operators are standing by.
SOURCE Fair Rate Funding
 

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Q&A with Jeff Schell, CEO of TranS1 – Fusing Innovation to the Spinal Sector

Fusing Innovation to the Spinal Sector (by Sean Fenske, Editor @ Orthopedic Design and Technology)
TranS1’s Jeff Schell shares his experience in securing the patent on a spinal fusion technology and supporting its growth.
TranS1’s AxiaLIF represents a disruptive technology in the spinal fusion sector for the lumbar region.
It’s not often that you hear of a true treasure being “rescued” from a bankruptcy auction (especially in the medtech space), but in the case of TranS1, that’s exactly what its CEO, Jeff Schell, made sure happened. Recognizing the importance of the technology for several years prior, Schell moved quickly when he learned of Baxano Surgical’s impending exit from the industry. As a result, he secured a technology for his company that he viewed as a true disruptive innovation within the spine fusion sector. “AxiaLIF provides a strong foundation at the L5-S1 joint to enable many patients to return to active lifestyles. AxiaLIF remains a key advance in spine surgery over the past twenty years. The company continues to develop a robust product portfolio around AxiaLIF as its core product,” explained Schell during an interview with ODT. In the following presentation, Schell explains the strategy he’s taken with regard to securing the AxiaLIF technology, the opportunities it offers, how his company is continuing to support it, and what’s coming in the years ahead.
 
 
 
 
 
Sean Fenske: Please tell me a bit about TranS1.
Jeff Schell: TranS1 is a spinal device company dedicated to improving patient outcomes. Headquartered in Denver, Colo., the company features a product line that provides a foundation for living well. Driven by surgeon innovation, the team includes experienced R&D, sales, legal, and management professionals who focus on resilient and continuous training, employing best-in-class training methods that ultimately benefit patients. In particular, the R&D focus of the company has led to its hiring a team of engineers, Ph.D.s, and other experts to assist with development of paradigm-shifting technologies in spine surgery.
Fenske: The company “salvaged” the AxiaLIF technology from a bankruptcy auction. Can you tell me about that experience?

Schell: I learned about the impending dissolution of Baxano Surgical in 2014. For several years prior, I followed the AxiaLIF product very closely, knowing that its unique approach represented one of the most significant advances in spine surgery over the past few decades. Many surgeons around the country continue to share this sentiment. As a patent lawyer, I also knew of the true value of the intellectual property portfolio associated with AxiaLIF. More than 100 patents of significant value and importance suddenly became available during the dissolution of Baxano. The product had real importance for surgeons and patients alike.
I started several companies in Denver during 2013-2014, including Rocky Mountain Patent and Quandary Medical, which began commercializing its own medical devices. When Baxano announced its dissolution, I saw the need to act quickly to acquire the AxiaLIF technology. I, along with many in the spine surgery community, viewed the technology as, by far, the most important piece of Baxano’s portfolio. Over December 2014 and January 2015, I worked to secure a financing facility of several million dollars to both acquire and support the AxiaLIF procedure, along with our other R&D initiatives. I have heard from several surgeons, investors, and spine company executives that they had significant interest in acquiring the product portfolio; I feel fortunate that TranS1’s vice president, Walker Wells, was able to win the auction for the AxiaLIF while at the same time negotiating an excellent price point. We were fortunate to acquire the AxiaLIF technology and its IP at a price that enabled us to have ample capital to re-energize the supply chain, compliance, enforcement, marketing, public relations, and, most importantly, surgeon support operations for AxiaLIF.
Fenske: Was this just a fortunate situation or is there strong interest in securing technology via this method?

Schell: I view AxiaLIF as one of the most important options for treatment of degenerative disc disease and spondylolythesis at the L5-S1 joint. I have been involved in healthcare and surgical operations for over a decade. During that time, I developed relationships with many spine surgeons. Most of those surgeons share their opinion that AxiaLIF represents one of the most important options for treatment of pathology at L5-S1. The technology has fallen into good hands.
To answer your question more specifically though, we are not in a habit of acquiring IP and technology from bankruptcy proceedings, but we would have gone anywhere in the world to buy the AxiaLIF. It was too promising of an approach—too disruptive to the status quo of L5-S1 fusion—for us to miss the opportunity.
Fenske: Tell me more about the AxiaLIF technology. How is it different from other solutions indicated for the treatment of the lumbar region?

Schell: As numerous peer-reviewed studies demonstrate, AxiaLIF accomplishes a 94 percent fusion rate while minimizing blood loss, lowering time needed in the operating room, and reducing the length of stay in the hospital compared to the alternatives at L5-S1. Properly selected patients can regularly receive AxiaLIF and leave the hospital or surgery center the same day, which makes sense as it requires the smallest incision.
Unlike other procedures, some of which usually require the removal of an entire facet joint (TLIF); retraction of the dura, which can lead to nerve injury (TLIF/PLIF); or dissection through the abdomen, which can lead to vascular perforation (ALIF); the AxiaLIF’s alternative pre-sacral approach preserves bony supportive structures and avoids other complications. In fact, a retrospective review of over 9,000 cases indicated that AxiaLIF’s complication rate is less than two percent—much less than alternatives at L5-S1. The same study found that the main unique risk associated with AxiaLIF—bowel perforation—had a risk of less than one percent. The risk profile compared to the efficacy of the other L5-S1 spinal fusion procedures is well-studied (with over 75 peer-reviewed articles) and very favorable.
Briefly, the surgical steps of the procedure differ from other procedures. To access the L5-S1 area for AxiaLIF fusion, a surgeon makes a small incision next to the tailbone. The surgeon then follows the anterior surface of the tailbone with a dissector. Cannulas are placed to provide a working channel for the surgeon. The surgeon then utilizes the working channel to drill through the sacrum into the L5-S1 space. Our discectomy tools then allow for removal of disc material. The surgeon can then place bone graft and the AxiaLIF implants across the L5-S1 space to allow for fusion. The primary difference of the procedure is the approach. Many of the steps associated with the procedure, such as access, discectomy, placement of bone graft, and placement of an implant, are similar or identical to the other procedures, though those procedures take a different approach angle to the spine.
 
Editor’s Note: The following video offers an expanded view of surgical procedure associated with the AxiaLIF. Interview continues after it.

 

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No relationship between acetabular cup ‘safe zone’ and dislocations

OK TO PLACE ACETABULAR CUP OUTSIDE “SAFE ZONE?” (Orthopedics This Week)
In a retrospective study, Cleveland Clinic researchers set out to test the association between cup positioning and patient-reported functional and general health outcomes, as well as dislocation rate. Going in, the team hypothesized that cup positioning with reference to the native acetabular rim, rather than the reported safe zone, would affect dislocation risk and patient-reported outcomes. All participants received CT imaging when undergoing primary, unilateral total hip arthroplasty (THA) at a single academic center by six surgeons from March 2011-January 2015.
Carlos A. Higuera Rueda, M.D. is an orthopedic surgeon with Cleveland Clinic, Ohio, who co-authored the study. Asked how certain cup positioning might affect patient-reported functional and general health outcomes, he toldOTW, The positioning of the components, both acetabular and femoral, would dictate the hip range of motion free of impingement and potentially dictate the mechanics that rule the muscle function around the hip girdle. When the range of motion and the mechanics of the hip are affected, the gait and activities of daily living will be affected. The spine and other joint like the knee and ankle will be affected as well.”
“It was surprising to learn that there is no relationship between positioning the acetabular component on what historically has been defined as a ‘safe zone’ (using the anterior pelvic plane) to prevent instability and have better patient-reported outcomes. Alternatively, we found that the superior and anterior rim of the acetabulum can be used to define version and inclination of the acetabular component in relation to the native acetabulum (and indirectly to the pelvis) and this position correlated better with patient-reported outcomes. This may be explained by the relationship between pelvic tilt, spine anatomy with the hip and other variables that at least in this study are merely assumptions. Future studies should be done to define such relationships with the proposed definition of acetabular component placement.”

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Study proves that Single-Use and Reusable Surgical Instruments have equivalent carbon footprint

Study Compares Carbon Footprint of Single-Use and Reusable Surgical Instruments (Orthopedic Design and Technology)
A lifecycle study performed by Solvay Specialty Polymers and Medacta found that the carbon footprint of single-use instrumentation fabricated from high-performance polymers is neutral when compared to the average CO2 equivalent annual emission of a hospital using conventional metal re-usable instrumentation. (Credit: Solvay Specialty Polymers)
Solvay Specialty Polymers, a supplier of high-performance thermoplastics, reported the results of a major study challenging perceptions that single-use medical instruments have a negative environmental impact vs. reusable instruments. Conducted in conjunction with Medacta International, a manufacturer of orthopedic implants, neurosurgical systems and instrumentation, and Swiss Climate, an independent sustainability consultant, the report signals a significant cradle-to-grave lifecycle analysis to measure the environmental impact of high-performance polymers in healthcare applications.   “As industry-leading innovators and collaborators, both Solvay and Medacta have been at the forefront of the trend toward single-use medical instrumentation. Despite the tremendous promise of the single-use concept for reducing the frequency of hospital acquired infections, concerns over increased waste have led to the perception that single-use instrumentation is less environmentally friendly than traditional systems,” said Bianca Shemper, sustainability manager for Solvay Specialty Polymers. “With Medacta’s help, we methodically explored those concerns to determine whether the alleged environmental impact of a single-use instrument kit outweighed its clear potential benefits. Partnerships like this emphasize Solvay’s commitment to taking a leadership role in sustainable chemistry and environmental responsibility to help our customers foster environmentally friendly yet highly competitive new solutions.”   Applying the ISO 14044 standard for lifecycle analysis, the group focused its study on the cumulative environmental impact of a surgical instrument kit for knee replacement manufactured by Medacta. The kit is available with either all-metal reusable instruments (GMK) or with single-use instruments (GMK Efficiency) injection molded from several high-performance medical grade polymers from Solvay. The analysis encompassed the complete cradle-to-grave lifecycle of both kit options, including their raw materials, production, use and disposal, as well as post-use management, reuse and recovery.   Overall, the lifecycle analysis of Medacta’s surgery kit demonstrated that the carbon footprint of GMK Efficiency single-use instrumentation is neutral when compared to the average CO2 equivalent annual emission of a hospital using conventional metal re-usable instrumentation. These findings counter existing industry perceptions about the negative environmental impact of single-use instrumentation, and reinforce the viability of metal-to-plastic conversion for these applications. Further, the findings allowed Medacta to apply Swiss Climate’s respected CO2 Neutral stamp to its GMK Efficiency single-use surgical instrument kit for knee replacement.   Additional input from Swiss Climate found that GMK Efficiency single-use instrumentation eliminates the need for repeated washing and sterilization, which can save up to 115 gallons (435 liters) of water for each surgical knee procedure.   “Medacta has always been committed to providing solutions that are optimally safe and effective, delivering economic sustainability with highly innovative products, while respecting the environment,” said Francesco Siccardi, executive vice president of Medacta International. “Medacta’s latest innovation, GMK Efficiency single use instruments, is the ultimate evidence of this constant commitment.”   “Despite the debate over environmental impact, demand for single-use instruments is growing quickly due, in part, to their potential for reducing hospital acquired infections,” said Dane Waund, global healthcare market manager for Solvay Specialty Polymers. “To help customers more familiar with metal fabrication consider making this important transition, Solvay is committed to partnering with industry leaders like Medacta to evaluate the potential environmental impact of alternative solutions, and to usher in a new generation of safer and more innovative medical instrumentation.”
 
 

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