Smith & Nephew released its JOURNEY II Cruciate Retaining knee replacement implant at the American Academy of Orthopaedic Surgeons Annual Meeting 2014.
Sunday, March 30, 2014
Tuesday, March 25, 2014
HILLSBORO, Ore., March 24, 2014 /PRNewswire-iReach/ -- Long known for its orthopaedic implants for trauma to the extremities, Acumed is venturing into a new and expanding market it feels has not seen adequate innovation in recent years: orthopaedic implants and instrumentation for the surgical repair of fractures and joint disruptions of the pelvis.
Acumed's new Pelvic Plating System includes plates, screws and instrumentation designed to provide fixation for fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and pelvic ring as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
More specifically, the System features both strategically pre-contoured and un-contoured plates, pre-contoured in places where it may save time and add secure fixation, and un-contoured in places to allow for buttressing of fractures or varying patient anatomy. In addition, Acumed's new system allows for the option to bend any of the pelvic plates, utilizing instrumentation provided within the system.
Further, enhancements to traditional pelvic instrumentation (which include various pliers, cutters, clamps and drills) are incorporated with the intention to ease surgical techniques and reduce time in surgery to benefit both surgeon and patient.
Acumed's pelvic fracture system was developed in conjunction with leading trauma surgeons and is Acumed's first step in its plans to expand its presence in trauma.
"Acumed is focused on expanding our trauma presence in areas where we feel we can leverage engineering excellence and innovation to provide new solutions." says Rich Rice, Acumed Vice President of Extremities, Trauma and Biologics.
"We identified pelvic fractures as an indication where very little innovation has occurred in the last ten years," he adds. "Moreover, with the aging population in developed countries, we feel the incidence rate of pelvic fractures per year will increase and there will be a need for better solutions than are on the market today."
Wednesday, March 19, 2014
DePuy Synthes Companies announced two new improvements to the company’s Attune Knee System on March 12, 2014 at the annual American Academy of Orthopaedic Surgeons meeting in New Orleans, Louisiana.
Thursday, March 13, 2014
As the effectiveness of anesthesia, pain management and rehabilitation continues to improve, more orthopaedic procedures are being done on an outpatient basis. In a new research study presented today at the 2014 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), same-day total joint replacement (TJR) patient outcomes were comparable to those of patients admitted to the hospital and staying at least one night following surgery. However, readmission rates, although statistically "non-significant," were higher for outpatient procedures. In a related study, a very low complication rate (.23 percent) was found in a review of more than 28,737 hand and upper extremity surgeries at an outpatient specialty clinic.
Many surgeons are now performing TJR as a same day procedure, with patients discharged within 24 hours of surgery. Outpatient TJR has "the potential benefit to cut costs and improve patient satisfaction," however, concerns for patient recovery, as well as increased Medicare scrutiny and financial penalties for unplanned hospital readmissions within 30 days of surgery, is deterring some doctors and hospitals from routinely performing outpatient surgeries, said David N. Vegari, MD, a Philadelphia orthopaedic surgeon and lead author of the study, "Implications of Outpatient vs. Inpatient Total Joint Arthroplasty on Hospital Readmission Rates."
In the study, researchers reviewed outcomes for 243 patients who underwent either outpatient (137 patients) or inpatient (106 patients) total knee or total hip replacement surgery between September 2010 and May 2011. Patients receiving outpatient surgery had a body mass index (BMI) less than or equal to 40 kg/m2, as well as no cardiopulmonary issues, sleep apnea, history of deep venous thrombosis or pulmonary embolus (blood clots). To qualify for outpatient surgery, patients also had to live less than one hour from the hospital and have "good" family support. The inpatient group had comparable pre-surgical qualifications, but per surgeon preference, stayed in the hospital for two days.
Following the surgery, each patient completed a telephone survey consisting of 14 questions related to hospital readmissions, unplanned care and patient satisfaction.
Among the outcomes:
- Of the 137 outpatient procedures (THA and TKA), 14 patients (10.2 percent) were readmitted within a 30-day period following surgery while seven of 106 inpatient THA and TKA (6.6 percent) procedures (6.6 percent) required hospital readmission within 30 days. This difference was not statistically significant.
- When including emergency department (ED) visits and urgent care visits as unplanned care episodes to the readmission number, 17 (12.4 percent) of outpatients required either hospital readmission or an unplanned care episode compared to seven (6.7 percent) inpatient TJRs.
- Only one (2.2 percent) of the outpatient THA patients was readmitted within 30 days of surgery and no inpatient THAs required readmission.
- The length of hospital stay had no effect on patient satisfaction measurements.
Outpatient TJR has "the potential benefit to cut costs and improve patient satisfaction," said Dr. Vegari. "With the trend toward higher readmissions in outpatient surgery, larger studies are needed to better understand the causes. By doing so, we can potentially help lower these rates to improve safety and efficacy of outpatient surgery."
In the related study, "The Safety of Outpatient Hand and Upper Extremity Surgery – A Statistical Review of Complications in 28,737 Cases," presented on Wednesday, March 12, adverse events were defined as those causing harm to a patient or leading to additional treatment. Using state reportable adverse events criteria as a guideline, the cases were divided into seven categories: infection, post-operative transfer to a hospital, wrong site surgery, retention of a foreign object, post-operative deep vein thrombosis, medication error and other "surgery-related complications." The adverse events were then analyzed to see if they led to additional laboratory testing, hospital admission, return to the operating room, emergency department visits, and/or physical or mental disability.
Among the findings:
- There were 65 reportable events for an overall complication rate of .23 percent. There were no mortalities.
- There were 21 infections (.7 percent), of which 10 were treated with antibiotics and one returned to the operating suite for incision and drainage. Seventeen patients (.06 percent) were transferred from the surgery center to the hospital post-operatively. The causes of the post-operative transfers included: irregular heart rhythms, uncontrolled hypertension, low-oxygen saturations, issues with pain control, drowsiness and generalized seizures.
- Twenty-one patients (.7 percent) were admitted to the hospital during the post-operative period, most often for poor pain control.
- There were no cases of wrong site surgery or retained foreign bodies.
- There was one case of post-operative pulmonary embolism, and one medication error that led to a rash.
- Four patients were returned to the operating room due to excessive bleeding or hematoma formation.
"With proper patient selection, extremely low complication rates can be achieved in hand and upper extremity surgery in outpatient surgery centers," said Sameer Jain, MD, a University of Pittsburgh orthopaedic surgeon specializing in sports medicine and hand and upper extremity surgery and lead study author of the study. "This is important, because as the cost of medicine rises and anesthesia continues to improve, more and more procedures are being completed on an outpatient basis.
"Our study supports the view that outpatient surgery can offer patients and physicians options for safe, cost-effective surgical care, offering improved patient comfort, increased efficiency and low complication rates," said Dr. Jain.
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Published at - PR News Wire
Researchers have found that sutures embedded with stem cells led to quicker and stronger healing of Achilles tendon tears than traditional sutures, according to a new study published in the March 2014 issue of Foot & Ankle International (published by SAGE).
Achilles tendon injuries are common for professional, collegiate and recreational athletes. These injuries are often treated surgically to reattach or repair the tendon if it has been torn. Patients have to keep their legs immobilized for a while after surgery before beginning their rehabilitation. Athletes may return to their activities sooner, but risk rerupturing the tendon if it has not healed completely.
Drs. Lew Schon, Samuel Adams, and Elizabeth Allen and Researchers Margaret Thorpe, Brent Parks, and Gary Aghazarian from MedStar Union Memorial Hospital in Baltimore, Maryland, conducted the study. They compared traditional surgery, surgery with stem cells injected in the injury area, and surgery with special sutures embedded with stem cells in rats. The results showed that the group receiving the stem cell sutures healed better.
"The exciting news from this early work is that the stem cells stayed in the tendon, promoting healing right away, during a time when patients are not able to begin aggressive rehabilitation. When people can't fully use their leg, the risk is that atrophy sets in and adhesions can develop which can impact how strong and functional the muscle and tendon are after it is reattached," said Dr. Schon. "Not only did the stem cells encourage better healing at the cellular level, the tendon strength itself was also stronger four weeks following surgery than in the other groups in our study," he added.
"Stem Cell-Bearing Suture Improves Achilles Tendon Healing in a Rat Model" by Samuel B. Adams, Jr, MD; Margaret A. Thorpe, BS; Brent G. Parks, MSc; Gary Aghazarian, BS; Elizabeth Allen, MD; and Lew C. Schon, MD in the March 2014 Foot & Ankle International.
Published at - Eurek Alert
Tuesday, March 11, 2014
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, announced today that it has entered into a definitive agreement with entities affiliated with two institutional investors in connection with a private placement of approximately $10 million aggregate principal amount of subordinated convertible debentures and warrants to purchase 9,428,000 shares of common stock. Prior to the closing of the private placement, the Company is required to obtain stockholder approval to increase the total number of its authorized shares of common stock and to approve the issuance of common stock pursuant to the debentures and warrants.
The debentures will be convertible into common stock at an initial conversion price of $1.06 per share and will bear interest at 6% per year, maturing on March 11, 2017. The warrants will have an initial exercise price of $1.19 per share. "We are pleased to have entered into this financing transaction. We plan to use the proceeds to expand our product portfolio through the development of the Avance™ pedicle screw system, and to execute our commercial growth strategy as we continue to penetrate the minimally invasive spine market," commented Ken Reali, President and CEO of Baxano Surgical.
About Baxano Surgical, Inc.
Baxano Surgical, Inc. is a medical device company focused on designing, developing, and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region. Baxano Surgical currently markets the AxiaLIF® family of products for single and two level lower lumbar fusion, the VEO® lateral access and interbody fusion system, iO-Flex®, a proprietary set of flexible instruments used by surgeons during spinal decompression procedures and the iO-Tome® instrument, which rapidly and precisely removes bone, specifically the facet joints, which is commonly performed in spinal fusion procedures. Baxano Surgical was founded in May 2000 and is headquartered in Raleigh, North Carolina. For more information, visit www.baxanosurgical.com. AxiaLIF, VEO, iO-Flex and iO-Tome are registered trademarks of Baxano Surgical.
Published at - Globe Newswire
Monday, March 10, 2014
Mainstay Medical today announced that it has secured approval from Ethics Committees in Australia to start a clinical trial of ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain (CLBP). Recruitment of subjects for the trial has commenced at three clinical sites in Australia.
One of the root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from chronic low back pain.The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain for whom surgery is not indicated.
“Our novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of the therapy was demonstrated in the recently completed European Feasibility Study.” said Peter Crosby, the CEO of Mainstay Medical. “The energy and experience of the Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results.”
People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and most of these people have no indications for spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.
“Back pain specialists from all over the world have told us that they need a new approach to help the large group of people with CLBP who are stranded without a viable alternative. We believe, based on published research, that there are millions of such people in Europe and the USA today. The results of the European Feasibility Study encouraged us to believe that ReActiv8 can play an important role in helping these people,” Crosby mentioned.
Results from Mainstay Medical’s European Feasibility Study were presented at the meeting of the International Neuromodulation Society in Berlin in June 2013. Results showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from CLBP and an improved quality of life.
About Mainstay Medical Ltd
Mainstay Medical Limited is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.
The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States and Australia.
Mainstay Medical is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).
Arthrosurface, Inc. (www.arthrosurface.com), a developer of less-invasive joint restoration systems, received FDA Clearance for its new ToeMotion™ Total Toe Restoration System, which it will launch at the AAOS meeting in New Orleans next week. Using its patented and proven fixation technology, the ToeMotion™ system consists of a Metatarsal based HemiCAP® implant and a new inlay metal baseplate with a poly insert for the phalangeal side of the joint. Both sides of the Metatarsal joint will now benefit from the tapered fixation post design which has been successfully used for almost 10 years. The ToeMotion™ system provides proven fixation, while the inlay implants preserve bone. Because it is implanted by milling instead of by using saw cuts, the ToeMotion™ system avoids resecting the intrinsic tissues that provide stability to the toe.
The surgeon designer behind the implant, Dr. Thomas San Giovanni, from the University of Miami, said, "For many years we have been using the metatarsal based HemiCAP® with great success. However, there are patients that require an implant on both sides of the joint, rather than a fusion, so now we can offer a motion preserving option to those patients looking to maintain an active lifestyle. In Florida, our patients are active and outdoors all year long so they are looking for an active alternative to fusion. Never moving their toe again is not a very appealing option to them, so this is why I have been working with Arthrosurface to design a system that would be minimally invasive, stable and allow my patients to maintain their motion."
The AAOS meeting will be held in New Orleans next week and Arthrosurface plans to showcase the product as part of its extremity portfolio. In the last few years, Arthrosurface has been rapidly expanding its design efforts to bring new Foot and Ankle products to the market, leveraging the success it has had with its industry leading joint restoration systems for the Shoulder.
Steve Ek, CEO and co-founder of Arthrosurface stated "the extremities market is providing an excellent opportunity for growth over the next several years. As such, we are targeting to launch another 5 extremity products along with the new ToeMotion™ system. Our platform technology for rock-solid immediate fixation and inlay arthroplasty has been proven to work on many different joints. But, what is really exciting is how well suited inlay arthroplasty is for the extremity joints. These joints are inherently smaller, very mobile and traditionally have not done very well with larger more invasive implants that require a lot of bone removal. Smaller implants that restore anatomy and take away very little bone is the wave of the future."
Arthrosurface, Inc. is a leader in the design and distribution of orthopedic devices for joint preservation, restoration and resurfacing. The HemiCAP® system is a unique, less invasive technology that can be used to treat a wide variety of joint conditions caused by trauma, injury and disease. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world.
Published at - PR Newswire
Wednesday, March 5, 2014
News - Exactech Celebrates 20 Years of Exactech Knee with Launch of New Real-Time Patient-Specific Solution in TKA
Exactech, Inc., a developer and producer of bone and joint restoration products, commemorates the twentieth anniversary of its knee system with the launch of ExactechGPS® Guided Personalized Surgery, the first advanced surgical technology to provide orthopaedic surgeons with a truly real-time patient-specific solution in total knee arthroplasty.
As a pioneer of knee replacement, Exactech used its surgeon- and engineer-driven principles to merge sophisticated technology with innovative instrumentation, offering surgeons real-time control for total knee arthroplasty. With an easy-to-read graphical interface on a touch screen in the sterile field and streamlined operative flow, ExactechGPS allows surgeons to fully understand the knee anatomy through instantaneous data and imaging, which can be an invaluable reference in their decisions regarding bone removal and where to position the implant based on the anatomical structure of the patient.
“ExactechGPS introduces a new concept that offers surgeons the benefits of a patient-specific solution in total knee replacement with the precision and accuracy of navigation, creating a new space in the market for advanced surgical technologies,” Exactech President David Petty said. “Through early clinical evaluations, surgeons who use conventional instrumentation and those who use advanced surgical technologies have had remarkable response and positive results.”
ExactechGPS supports a wide array of soft tissue strategies, ligament balancing options and less invasive approaches and techniques. Through mechanical testing, ExactechGPS has demonstrated a high level of accuracy and precision to within one degree and one millimeter of variability.1 Medical literature documents the importance of precise implant alignment for implant longevity.2
At the 2014 American Academy of Orthopaedic Surgeons annual meeting, Exactech will also introduce a patented real-time guide, which allows for simple positioning of the femoral resection through a single, navigated device.
“Twenty years ago, Exactech made a commitment to develop a comprehensive knee system that would meet the wide range of total knee replacement patients,” Petty said. “With this exciting launch, Exactech showcases its investment in providing innovative solutions to better patient outcomes.”
The launch coincides with the twentieth anniversary of the Exactech Knee system — a system that has been recognized for delivering performance over time1with proven, time-tested design, proprietary net compression molded polyethylene and excellent long-term implant survivorship and clinical outcomes.1
Some of the highlights of the Exactech Knee system:
- Strong four-decade design lineage with roots beginning with the Total Condylar and Insall/Burstein knees.
- Excellent long-term clinical outcomes, including 97.2 to 98.6 percent documented implant survival rates.1
- Proprietary net compression molded polyethylene inserts maintain oxidation resistance and fracture toughness and have demonstrated excellent wear characteristics.1
- Patented design offers improved congruency and patella tracking and a tibial tray locking mechanism that reduces insert motion and disassociation.1
- Optetrak Logic PS removes 30 percent less bone than a traditional notch resection and is designed to maximize stability and range of motion while providing surgeons with an easier, faster and more consistent notch preparation.1
- Optetrak Logic CR offers a unique surgical technique and implant system to maintain the anatomical integrity of the posterior cruciate ligament. A selection of CR Slope® inserts allows surgeons to easily balance flexion-extension gaps.
- Optetrak Logic PS Constrained and CR Constrained inserts allow surgeons to easily transition intra-operatively to an increased constraint insert without additional bone preparation.
- Low Profile Instrumentation features user-friendly instruments and a modular case design for greater efficiencies in the O.R.
Live demos of the ExactechGPS technology will be held next Wednesday, March 12, through Friday, March 14, at Exactech’s Booth #2261 during the AAOS 2014 Annual Meeting. More information about this and other Exactech innovations is available at www.exac.com/academy.
1. Data on file at Exactech, Inc.
2. Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement: its effect on survival. Clin Orthop Relat Res. 1994; 299: 153-156
News - Proception Medical, LLC. partners with Private Equity Fund to Evaluate Orthopaedic and Other Medical Device Investment Opportunities
Proception Medical, LLC., a medical device incubator which in-licenses commercially viable inventions from surgeon inventors and develops them with the goal of exiting to an appropriate strategic partner, has partnered with a private equity fund to seek and evaluate private investment and buy-out opportunities in the orthopaedic and medical device industries.
Members of Proception Medical will be attending the Annual American Academy of Orthopaedic Surgeon Meeting in New Orleans next week to investigate investment and new product opportunities.
Proception Medical bridges the gap between surgeon inventor and strategic exits by taking the device through the development, regulatory approvals and limited launch process. The partnership with the private equity firm allows Proception Medical to create similar value for companies needing investment or buy-out capital to achieve the next stage of growth, as they do for the surgeon inventor.
The fund is looking at investment opportunities into revenue positive companies with sales up to $25M as well as product divestitures.
About Proception Medical, LLC. Proception Medical, LLC. has a singular mission: value creation. As a medical device incubator, their goal is to in-license commercially viable inventions, develop them with a team of talented engineers, obtain the necessary commercialization approvals, then take them through a rigorous beta and limited launch with world class surgical partners. Their end goal is to then exit a clean, proven product, quickly, to an appropriate strategic partner.
Published at - PR News Wire
Tuesday, March 4, 2014
Invuity, Inc., a developer of advanced medical devices to dramatically improve access and visualization in minimally invasive and minimal access surgeries, announced today that it has secured $36 million in a Series E financing led by HealthCare Royalty Partners (“HC Royalty”), along with existing investors Valence Life Sciences, InterWest Partners, Kleiner Perkins Caufield and Byers, and a number of other qualified investors. The financing is a combination of $21 million in equity and up to $15 million in debt. Proceeds will be used to accelerate commercial initiatives across the company’s broad and growing product line of advanced visualization devices for minimally invasive surgery.
“We have experienced considerable growth recently, with revenue more than doubling each year. This funding allows us to continue our strong momentum in a variety of high value procedures across multiple specialties,” said Sawyer. “Invuity is poised to accelerate product introductions and expand the commercialization team in the coming year. The executive team and our current investors are aligned in these goals and we are very pleased to welcome HC Royalty as an investor for the next phase of the company’s growth and expansion.”Invuity Chief Executive Officer Philip Sawyer explained that the largely equity deal also includes some debt, which provides for a lower cost of capital, as well as a less dilutive structure.
Gregory B. Brown, M.D., Founding Managing Director at HC Royalty, commented, “As a surgeon, I understand the challenges that inadequate illumination of the surgical site can present for both doctors and their staff. Invuity’s technology has demonstrated that better visualization results in safer and more efficient surgeries. We believe this technology has broad applications across multiple surgical specialties and presents an exciting, robust market opportunity.”
Invuity develops advanced medical devices to dramatically improve access and visualization in minimally invasive and minimal access surgeries. The company's products incorporate its proprietary Eigr technology into sophisticated hand-held illumination devices and access systems for a variety of surgical specialties including spine, orthopedics, breast and thyroid oncology and plastic surgery. The company is headquartered in San Francisco, CA. For more information, visit www.invuity.com.
About HealthCare Royalty Partners
HealthCare Royalty Partners is a global healthcare investment firm focused on providing financing solutions to healthcare companies and royalty owners with interests in approved pharmaceutical and medical device products. The firm`s senior investment team has participated in 50 royalty financings valued at over $2 billion over the past decade. For more information, visit www.healthcareroyalty.com.
Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostic company focused on spine imaging informatics, announced achieving the milestone of having tested over 1,000 patients with the Vertebral Motion Analysis (VMA) system, which was commercially launched on a limited scale in late 2013.
The VMA test is a revolutionary new diagnostic service that is an automated, standardized alternative to the current 1940’s era test for assessing spinal instability. Spinal instability is a condition that can cause severe back and neck pain, and is the number one most common primary diagnosis driving the 500,000+ spine fusion surgeries done in the US each year. The VMA has been shown in clinical studies and in commercial patients to detect instability that may be missed by the current test. For patients suffering from pain and their surgeons, this can be extremely useful information.
“Spine surgeons are talking with their actions and prescribing the VMA. They recognize the value of the diagnostic insights they receive from the VMA. We are thrilled and humbled by this success, and are focused on rolling out the VMA as quickly as possible to ensure all patients and surgeons have access to this revolutionary technology,” said Paul Gunnoe, CEO of Ortho Kinematics.
About Ortho Kinematics
Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and is on the web at www.orthokinematics.com. For more information contact Ortho Kinematics, Inc. at firstname.lastname@example.org.