CAESAREA, ISRAEL (PRWEB) JUNE 30, 2017
OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced the publication of positive data on the use of the InSpace™ subacromial spacer for the treatment of massive rotator cuff tears. The case series of 39 shoulders (37 patients) was published in Arthroscopy and demonstrated improved function and reduced pain in patients treated with the InSpace System.
“Patients who fail conservative therapy for massive rotator cuff repair have historically had few options for further treatment of this debilitating, painful condition,” said Julien Deranlot, M.D., principal investigator of the study and an orthopedic surgeon at Clinique Drouot in Paris, France. “The InSpace provides a safe and reliable surgical alternative that can improve shoulder pain and function, allowing patients to have a better quality of life post-operatively.”
The InSpace System consists of a biodegradable balloon spacer deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. It is usually placed arthroscopically in a procedure that requires only 10 minutes to perform.
This study assessed clinical, functional and radiographic outcomes for all patients with symptomatic massive irreparable rotator cuff tears who were treated with the InSpace at the Clinique Drouot between January 2011 and December 2014. Patients included in this study had a minimum of one year and up to three years of follow-up at the time of analysis.
The investigators reported the following results:
- Range of motion was significantly increased for all patients in anterior elevation, abduction and external rotation.
- The mean Constant score, which measures pain, activity level and function, improved from 40 (±14.6) (45 [±15.2] when adjusted for age and gender) at baseline to 59 (±13.7) at one year, and up to 64 (±13.6) (adjusted = 76 [±17.1]) (P < 0.0001) at last follow-up. Notably, there was a significant improvement between the one-year follow-up and three-year follow-up regarding the adjusted Constant score (P=0.02).
- At last follow-up, adjusted Constant score was excellent (greater than 100 points) for three shoulders (9%), good (86-99 points) for eight (23%), fair (65-85 points) for sixteen (45%), and poor (fewer than 65 points) for eight shoulders (23%).
- Among the radiographic outcomes, when assessing for Hamada score (a measure of osteoarthritis), four shoulders progressed by one radiographic stage (15%), and two shoulders progressed by three stages (4%). 32 shoulders had no progression during follow-up.
“We continue to be encouraged by the compelling clinical improvements we see in patients treated with the InSpace System, which are in line with the strong results demonstrated in previous studies,” OrthoSpace CEO Itay Barnea commented. “The system offers a safe, minimally invasive option that can be effectively used to relieve pain and improve shoulder function for patients, especially in elderly patients with chronic pain and disability, poor tissue quality or other health issues, who may not have alternative treatment options.”
The InSpace System is CE Marked in Europe and Israel and is investigational in the U.S. and Canada, where it is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients.
About OrthoSpace Ltd. OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.Read More
Posted 29 June 2017 - By Michael Mezher The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued an alert to healthcare professionals with updated recommendations for long-term follow-up for patients with metal-on-metal hip replacements. Safety and durability concerns about metal-on-metal hip replacements, along with a scandal involving faulty breast implants, were a driving factor in the EU's decision to overhaul its medical device and in vitro diagnostics regulations. Previously, MHRA's recommendations focused on larger metal-on-metal hip replacements (≥36mm) and certain implants made by Johnson & Johnson subsidiary DePuy Synthes, which were thought to be riskier than other types of metal-on-metal hips. In August 2010, DePuy recalled two models of its ASR hip replacement systems, and in 2013 the UK's National Health Service (NHS) stopped performing most metal-on-metal hip replacements, citing high failure rates. However, tens of thousands of patients in the UK still have the devices implanted. READ THE REST HERERead More
Zimmer Biomet Holdings Announces Live Audio Webcast and Conference Call of Second Quarter 2017 Results
WARSAW, Ind., June 30, 2017 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced its second quarter sales and earnings conference call will be broadcast live over the Internet on Thursday, July 27, 2017, at 8 a.m. Eastern Time. A news release detailing the quarterly results will be made available at 7:30 a.m. Eastern Time the morning of the conference call. The live audio webcast can be accessed via Zimmer Biomet's Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call. Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com. A digital recording will be available 24 hours after the completion of the conference call, from July 28, 2017 to August 26, 2017. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985. About the Company Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives. We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet. ZBH - Fin SOURCE Zimmer Biomet Holdings, Inc.
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BY BoneSupport said last week it closed its initial public offering, raising a total of approximately $57.1 million (SEK 500 million), not including an over-allotment option. The Swedish company, which is developing the Cerament G injectable antibiotic-eluting bone graft substitute, said it floated approximately 17.2 million new shares at $3.40 per share (SEK 29) in the round, raising approximately $57.1 million before issue costs and $54 million (SEK 461 million) after issue costs. Bonesupport also issued an over-allotment option for 2.6 million shares and an additional $8.7 million (SEK 75 million), bringing the total number of shares offered in the round to 48.8 million, according to a press release. READ THE REST HERERead More
Meditech Spine Releases CURE LP System and Talos® HA Peek Spacers as Comprehensive Solution for Surgeons
- A low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent bone screws anchored on the spine from loosening and backing out.
- Designed with a large graft window for viewing the interbody space.
- Pre-lordosed for lumbar sacral applications.
- Available for both anterior and lateral procedures as four-hole or two-hole plates.
Oska Wellness is Nominated in the 2017 Startup of the Year Competition – West [Pacific – Southern California]
Who should be named Startup of the Year from the West [Pacific – Southern California] region? You can share your opinion by voting for your favorite startup in our Reader’s Choice Poll below. Reader’s Choice Poll voting will help guide the selection of the top 100 startup semifinalists who will compete for cash, prizes and more, at the Innovate! and Celebrate conference in San Francisco on October 9th – 11th, 2017. The deadline to vote is July 12th. There’s a “Click to Vote” link next to each startup below, vote for the startup you like the best located in the West [Pacific – Southern California] region: Airspace Technologies (Carlsbad, CA) [Click to Vote] Airspace Technologies offers end-to-end logistics solutions: we take a modern approach to time critical shipments by enabling technology. Bezelhub (Santa Monica, CA) [Click to Vote] Bezelhub is jewelry in your pocket. Just tap a button and a luxury watch is delivered right to you, giving you the access you need, anywhere. Blue (Riverside, CA) [Click to Vote] Blue is a mobile application that introduces people using bluetooth low energy without the touch of a button. Bottlerocket (Santa Monica, CA) [Click to Vote] BottleRocket is the first on-demand service that rewards users for recycling. Decorator (Santa Monica, CA) [Click to Vote] Decorator is crowdsourcing interior design. Think The Sims for real-life homes where other people redesign your room with new paint & furniture. LineStar by Fantasy Sports Co. (San Diego, CA) [Click to Vote] Fantasy Just Got Fun Again as LineStar is the #1 Companion for DraftKings, FanDuel, and Yahoo Daily Fantasy! GoShare (San Diego, CA) [Click to Vote] GoShare connects truck and van owners with people and business who need help moving, hauling and delivering large items on demand. Lemonlight (Marina del Rey, CA) [Click to Vote] Lemonlight creates high-quality affordable video content at scale. In 3 years, the company has produced 4000+ videos for brands nationwide. LuxeRoom4Day (Beverly Hills, CA) [Click to Vote] LuxeRoom4Day is a simple, fast, and secure way to book a 5-star luxury hotel day rooms, with prices up to 70 percent cheaper than the night rates. Markett (Venice, CA) [Click to Vote] Markett is a performance based platform that systematizes word of mouth marketing by providing ambassadors with all the tools they need to acquire new customers for their favorite brands. Nutra.io (Playa Vista, CA) [Click to Vote] is an end-to-end solution to decoding your genetic data into actions to help you eat right and supplement your body based on your genome and track your results. Oska Wellness (Carlsbad, CA) [Click to Vote] Oska Wellness is a new health-tech, wearable pain relief device that can help areas of the body prone to injury and degeneration. Raken (Carlsbad, CA) [Click to Vote] Raken’s software is a shot of adrenaline for a construction industry still stuck in the paper and pencil era. Renly (Manhattan Beach, CA) [Click to Vote] A marketplace for renters and sub-renters. RepWatch (Westlake Village, CA) [Click to Vote] RepWatch promotes efficient recovery for physical therapy patients by providing a system that encourages and motivates patients to stay on track. SPARE. (Santa Monica, CA) [Click to Vote] SPARE. is a community-based cash network allowing cash-back without a purchase. We empower merchants to dispense cash directly from their cash registers and consumers order cash directly from their mobile devices. SwiftChange (San Diego, CA) [Click to Vote] SwiftChange lets you receive change on your phone after a cash payment so you can capture the value of change without the hassle of coins! Tampon Tribe (Santa Monica, CA) [Click to Vote] Tampon Tribe is a movement that offers affordable access to organic feminine hygiene via online subscription for $8 a month and deliver to your home. Trulo (Manhattan Beach, CA) [Click to Vote] Trulo is the home for your best kept secrets of your locals-only spots in your city that you share with your hand-selected travel tribe. Youngry (Newport Beach, CA) [Click to Vote] Youngry provides early stage entrepreneurs “Young In Spirit, Hungry In Ambition” the best mentor driven content on the planet. Thank you to our Startup of the Year sponsors and partnersRead More
DePuy Synthes Launches New Fenestrated Screw Systems Designed for Enhanced Fixation in Patients with Advanced Stage Spinal Tumors
RAYNHAM, Mass., June 29, 2017 /PRNewswire/ -- Today DePuy Synthes* announces the U.S. launch of the VIPER® and EXPEDIUM® Fenestrated Screw Systems. When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The fenestrated screw systems provide stabilization and palliative treatment for patients who may be suffering from spinal cord compression as a result of advanced stage tumors. Surgical treatment for patients with advanced stage spinal disease can be challenging with traditional pedicle screw systems, but using fenestrated screws with spinal cement can provide immediate screw fixation while stabilizing the spine. The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with fenestrations above the screw tip enable controlled delivery of CONFIDENCE High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation. "The ability to inject cement via fenestrated screws is a true game-changer in the field of spinal oncology," said Daniel Sciubba**, M.D., Director, Spine Tumor and Spine Deformity Surgery, Johns Hopkins Hospital. "The systems are reliable and easy-to-use and can seamlessly be incorporated into open and minimally invasive approaches. The cement working characteristics, delivery system and ability to use standard hardware and tools make the systems extremely efficient." The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery. The use of VIPER Fenestrated Screws combined with spinal cement can be used in minimally invasive surgery (MIS), a type of surgery that is associated with a reduction in operating room time, blood loss and lower infection rates. The VIPER Fenestrated Screws are compatible with the instrumentation of the VIPER and EXPEDIUM 5.5 Spine Systems, and the EXPEDIUM Fenestrated Screws are compatible with the instrumentation of the EXPEDIUM VERSE® Spinal System. Both fenestrated screw systems are now available nationwide. Indications for Use When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCETM High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. About DePuy Synthes Companies DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. *DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International SARL is the legal manufacturer of the VIPER® and EXPEDIUM® Fenestrated Screw Systems. **Consultant to DePuy Synthes Spine ***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment. ©DePuy Synthes 2017. All rights reserved. DSUS/SPN/0617/1615(1) SOURCE DePuy Synthes
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LONDON, June 29, 2017 /PRNewswire/ -- Smith & Nephew (NYSE: SNN; LSE:SN), the global medical technology business, today announces the launch of its NAVIO handheld robotics-assisted total knee arthroplasty (TKA) application. This expands the NAVIO platform to total knees, which comprise 80% of all knee replacement surgeries globally. The TKA application supports Smith & Nephew's JOURNEY II, LEGION Primary and GENESIS II Total Knee Systems. The NAVIO Surgical System is a next generation handheld robotics platform designed to aid surgeons with implant alignment, ligament balancing and bone preparation – key factors that can drive patient satisfaction. The small footprint of the NAVIO Surgical system allows for easy set up and portability. The TKA application provides a streamlined and efficient workflow along with cut guides specifically designed for handheld robotics-assisted surgery. Furthermore, the NAVIO robotics-assisted system does not require a preoperative image, such as a CT scan. This allows patients to receive the benefits of robotics-assistance without the extra steps, costs, and radiation associated with additional preoperative imaging. "The NAVIO system offers game changing improvements in precision and accuracy without sacrificing efficiency. It allows surgeons the control to create a patient-specific plan in the OR and the confidence to execute with robotic precision," says Dr Joseph Burkhardt from southwest Michigan. "For the Total Knee, it provides surgeons the ability to do more than they have ever been able to do with standard instruments, resulting in improved functional outcomes for the patient." "The NAVIO partial knee replacement application has been commercially available since 2014, including UKA and PFJ options, and has developed a strong surgeon following," said Glenn Warner, President, US Commercial. "The full market release of the TKA application provides a robotics-assisted solution for one of the largest markets in orthopaedics. Smith & Nephew is committed to continued expansion and growth of the NAVIO robotics-assisted platform." About Smith & Nephew Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE: SNN). For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com. Forward-looking Statements This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations. ™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office. SOURCE Smith & Nephew
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Stryker Unveils Hoffmann LRF Hexapod With Pre And Post-Operative Planning Tool For Deformity Correction & Limb Reconstruction Procedures
- VariAx 2® Fracture Plates VariAx 2® Fracture Plates are SOMA designed for an enhanced fit. These plates are available in a variety of lengths and sizes (two to seven holes), offered in slim and broad options, and indicated for the foot, ankle, hand and wrist.
- ToeTac ToeTac is a sterile-packed PEEK cannulated hammertoe fixation product that does not require cold chain storage and includes cup and cone reamers allowing for simple K-wire fixation of adjacent joints.
- M.O.R.E. (Mobile Operating Room Experience) M.O.R.E. is designed to educate the entire surgical care team on Stryker's products and surgical techniques, providing a hands-on experience in their local community.