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West Sacramento-based bone graft company raises funds, wins federal clearance
Molecular Matrix Inc. has raised money and passed a major regulatory milestone for its product that helps bone heal. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - January 19, 2018 Category: Health Management Authors: Mark Anderson Source Type: news

New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers
DENVER, Jan. 10, 2018 -- (Healthcare Sales & Marketing Network) -- Kleiner Device Labs today announced full commercial availability of a new spinal bone graft delivery tool, the KG® 1, featuring a patented design that facilitates less-invasive procedu... Devices, Oncology, Neurosurgery, Product Launch Kleiner Device Labs, bone graft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 10, 2018 Category: Pharmaceuticals Source Type: news

Do I have to place a membrane in this immediate implant case?
I placed an implant in the maxillary lateral incisor site immediately after extraction and did a small particulate bone graft. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - January 5, 2018 Category: Dentistry Authors: osseonews Tags: Clinical Questions Surgical Source Type: news

RTI Surgical buys Zyga Tech and its SImmetry sacroiliac fusion device, updates 2018 outlook
RTI Surgical (NSDQ:RTIX) yesterday announced an agreement to purchase Zyga Technology and its SImmetry sacroiliac joint fusion system and today released updated guidance for 2018 and beyond. The Alachua, Fla.-based RTI surgical said that Zyga Technology has approximately 30 employees and $4 million in annual revenue, and that it plans to fund the acquisition through a combination of cash and through borrowing under its existing credit facility. Terms of the deal were not disclosed, and RTI Surgical it expects the deal to close when the Delaware Department of State re-opens as it is currently closed due to incleme...
Source: Mass Device - January 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Spinal RTI Surgical Source Type: news

NuVasive wins expanded FDA nod, launches interbody fusion devices
NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device. Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September. The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said. “Our strategy in building our AMS portfolio is to ...
Source: Mass Device - January 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news

Distants between implants considerable: long-term success?
I placed 2 implants in the maxillary right posterior quadrant using an indirect sinus lift without bone grafts.  I am concerned about a few issues. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - January 2, 2018 Category: Dentistry Authors: gkaplowitz Tags: Clinical Cases Surgical Source Type: news

Anika Therapeutics wins FDA nod for bone void filler
Anika Therapeutics (NSDQ:ANIK) said today that it won 510(k) clearance from the FDA for its hyaluronic acid-based bone void filler The indication covers filling bone voids or defects that aren’t intrinsic to the stability of the bone, created during surgery or the result of traumatic injury. Made of a synthetic, biocompatible bone graft substitute material, the filler is injected into a void and hardens at body temperature. It’s then resorbed and replaced by new bone growth. Get the full story at our sister site, Drug Delivery Business News. The post Anika Therapeutics wins FDA nod for bone void filler appeared...
Source: Mass Device - December 27, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Anika Therapeutics Inc. Source Type: news

Flapless procedure with no graft: Failing or Not?
I placed an immediate 3.5x13 Nobel Replace conical connection implant in area #7 using a flapless procedure with gap space about 1mm to 1.5, which was impossible to fill with bone graft. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - December 18, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Surgical Source Type: news

Knee Stability and Alterations in Synovial Fluid After Arthroscopic ACL Reconstruction With Hamstring Autograft or Hamstring Allograft
No abstract available (Source: Lippincott's Bone and Joint Newsletter)
Source: Lippincott's Bone and Joint Newsletter - December 17, 2017 Category: Orthopaedics Tags: CME Article Source Type: news

Dehydrated Amniotic Membrane Allograft for Extremity Wounds Dehydrated Amniotic Membrane Allograft for Extremity Wounds
What benefits might this novel amniotic allograft offer in the treatment of lower extremity wounds?Wounds (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 15, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

Medtronic Settles States' Probe Into Infuse Marketing for $12 Million Medtronic Settles States' Probe Into Infuse Marketing for $12 Million
Medtronic Plc has agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said on Wednesday.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Medtronic Forks Over $12 Million in Deceptive Marketing Settlement
Medtronic has agreed to pay a total of $12 million in a five-state settlement of litigation over its controversial Infuse bone graft device. Oregon Attorney General Ellen Rosenblum announced the settlement with Medtronic Sofamor Danek Inc. and Medtronic Sofamor Danek USA Inc. to resolve allegations that the company unlawfully promoted Infuse, used in spinal fusion procedures, to doctors. Other states participating in the settlement are California, Illinois, Massachusetts, and Washington. Oregon alleged that Medtronic made deceptive claims about Infuse by using trusted scientific publications to rep...
Source: MDDI - December 14, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Regulatory and Compliance Medical Device Business Source Type: news

Sintered Xenograft over Allograft?
There is an article which describes using sintered xenograft (bovine) over an allograft for Ridge Augmentation. Any thoughts on this technique? (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - December 14, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Medtronic to pay $12m to settle Infuse false marketing claims
Medtronic‘s (NYSE:MDT) spinal devices division has agreed to pay $12 million to settle allegations that the medtech giant made false claims to doctors and patients about its Infuse bone-growth protein, according to a Star Tribune report. States joining in the settlement include California, Massachusetts, Illinois, Washington and Oregon, according to the report. In Oregon, Attorney General Ellen Rosenblum said that Medtronic Sofamor Danek agreed to settle claims that it manipulated journal articles to make its controversial Infuse protein appear safer than it was to sell more products, breaking Oregon law, the Star Tr...
Source: Mass Device - December 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Spinal Medtronic Source Type: news

Medtronic settles states' probe into Infuse marketing for $12 million
BOSTON (Reuters) - Medtronic Plc has agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - December 13, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

C-reactive protein promotes bone destruction in human myeloma through the CD32-p38 MAPK-Twist axis
Bone destruction is a hallmark of myeloma and affects 80% of patients. Myeloma cells promote bone destruction by activating osteoclasts. In investigating the underlying mechanism, we found that C-reactive protein (CRP), a protein secreted in increased amounts by hepatocytes in response to myeloma-derived cytokines, activated myeloma cells to promote osteoclastogenesis and bone destruction in vivo. In mice bearing human bone grafts and injected with multiple myeloma cells, CRP bound to surface CD32 (also known as FcRII) on myeloma cells, which activated a pathway mediated by the kinase p38 MAPK and the transcription factor ...
Source: Signal Transduction Knowledge Environment - December 12, 2017 Category: Science Authors: Yang, J., Liu, Z., Liu, H., He, J., Yang, J., Lin, P., Wang, Q., Du, J., Ma, W., Yin, Z., Davis, E., Orlowski, R. Z., Hou, J., Yi, Q. Tags: STKE Research Articles Source Type: news

State of the U.S. Market for Dental Bone Graft Substitutes and Other Biomaterials
The dental bone graft substitute and other biomaterials market includes dental bone graft substitutes (DBGS), dental growth factors, and dental barrier membranes. The DBGS market is relatively stable with an increasing shift towards allografts. Already representing the largest segment of total DBGS materials, the allograft market is expected to grow at a 5.8% compound annual growth rate (CAGR) by 2023. The most innovative market in dental biomaterials is dental growth factor technology. However, these products have been slow to make strides on the market due to their relatively high price point. As such, growth within the ...
Source: MDDI - December 9, 2017 Category: Medical Devices Authors: Salma Mashkoor and Celine Mashkoor Tags: Materials Source Type: news

Bone Resorption During Submerged Healing After Guided Bone Regeneration: A Prospective Case Series
Conclusion: Loss in graft quantity was observed after ridge augmentation using an allograft and nonresorbable membrane during submerged healing before implant placement. Further studies with larger sample sizes are recommended to confirm its findings. (Source: Dental Technology Blog)
Source: Dental Technology Blog - December 4, 2017 Category: Dentistry Source Type: news

Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017
Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately. Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing Chris Fair, who will stay on as a board member with the company. “I am excited by the opportunity to lead our talented team of employees and partners and create an even more vibrant and dynamic Spinal Elements in the years ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Abbott Alphatec Apica Cardiovascular Bovie Medical Corp. Cardiovascular Systems Inc. Dentsply Sirona Guidant Corp. Lima Corporate Medical Device Innovation Consortium MedLumics MedTech Europe Medtronic Nuv Source Type: news

MiMedx Provides Update On Its Reimbursement Coverage
MARIETTA, Ga., Nov. 21, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts ... Regenerative Medicine, Reimbursement MiMedx, EpiFix, Venous Leg Ulcer, Diabetic Foot Ulcer (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 21, 2017 Category: Pharmaceuticals Source Type: news

RTI Surgical reveals FDA warning letter over Map3 allograft classification
RTI Surgical (NSDQ:RTIX) today revealed a warning letter it received from the FDA related to processes used to manufacture its Map3 cellular allogeneic bone graft over issues with the regulatory classification of the product. The Alachua, Fla.-based company said it received the letter on November 9 based on an inspection of its facilities from April and that it is preparing an appropriate response to the letter. In the letter, the FDA asserted that the Map3 allograft could not be regulated solely as a human cell, tissue and cellular and tissue-based product, but that the product was also subject to regulations applica...
Source: Mass Device - November 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regenerative Medicine RTI Surgical Source Type: news

Hologic to retain CEO MacMillan | Personnel Moves – November 3, 2017
Hologic (NSDQ:HOLX) said this week its current prez and CEO Stephen MacMillan will stay on with the company, resolving rumors that he may depart it to take up the corner office at Zimmer Biomet (NYSE:ZBH). In an SEC filing, the Marlborough, Mass.-based company’s board said it approved a special “performance-based retention equity grant” to MacMillan after he had begun to receive interest from other medical device firms. “Mr. MacMillan has led a dramatic turnaround of Hologic since joining in December 2013. The company’s performance has increased significantly under his...
Source: Mass Device - November 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News ConMed Corp. Hologic Invacare kentimaging Meritech Capital Partners Pulmatrix Inc. Sanofi-Aventis Smith & Nephew Tissue Regenix zimmerbiomet Source Type: news

Wright Medical shares tumble on Q3 sales miss, growing losses
Shares in Wright Medical (NSDQ:WMGI) fell today after the medical device maker missed sales expectations on Wall Street with its 3rd quarter earnings results. The Netherlands-based company posted losses of $131.9 million, or $1.26 per share, on sales of $170.5 million for the 3 months ended September 30, seeing losses grow 19.7% while sales grew a smaller 8.4% compared with the same period last year. Adjusted to exclude 1-time items, losses per share were 16¢, just ahead of the 17¢ consensus on Wall Street, where analysts expected to see revenue of $173.6 million. “Our U.S. upper extremities business h...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup wrightmedical Source Type: news

MiMedx Agrees To Lawsuit Settlement With Halo Wound Solutions
MARIETTA, Ga., Nov. 1, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts a... Devices, Regenerative Medicine, Wound Care, Litigation MiMedx, Halo Wound Solutions (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 1, 2017 Category: Pharmaceuticals Source Type: news

Arthrosurface acquires allograft tech from Wasas
Arthrosurface said today that it paid an unspecified amount to acquire an acellular dermal stabilization device technology from Wasas LLC. Derived from human tissue, acellular dermis is made using a process that removes cells but retains portions of the extracellular matrix to create dermal allografts. The deal includes the patent rights for the technology, which Franklin, Mass.-based Arthrosurface plans to develop and market “a platform of novel methods to be used to correct orthopedic challenges” for several indications. Wasas is based in Ft. Lauderdale. “The availability of this allograf...
Source: Mass Device - October 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Orthopedics Wall Street Beat Arthrosurface wasas Source Type: news

NASS 2017 Roundup: Zimmer Biomet launches Vitality+, Vital spinal fixation systems
Zimmer Biomet (NYSE:ZBH) today announced the launch of its Vitality+ and Vital spine fixation systems in the US following recent 510(k) clearance for pedicle preparation and screw insertion under power. The Vitality+ spinal fixation system is composed of a Vitality+ Power designed for controlled pedicle preparation and pedicle screw insertion, Vitality+ PSO designed for optimal pedicle subtraction osteotomy and vertebral column resection and Vitality+ Hooks for additional fixation options, the Warsaw, Ind.-based company said. The recent clearance allows the inclusion of the market’s first flexible drill and blun...
Source: Mass Device - October 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Spinal depuysynthes gssolutions johnsonandjohnson LifeNet Health Misonix Mizuho OSI Nuvasive RTI Surgical Xtant Medical zimmerbiomet Source Type: news

LifeNet Health Provides Uncompromised Fusion Solution with Launch of PliaFX(R) Strip
Presentations at NASS Annual Meeting (Booth 1113) will highlight the technology behind PliaFX Strip ORLANDO, Fla., Oct. 25, 2017 -- (Healthcare Sales & Marketing Network) -- LifeNet Health has introduced its latest allograft bone-healing solution, the ... Devices, Orthopaedic, Product Launch LifeNet Health, PliaFX, allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 25, 2017 Category: Pharmaceuticals Source Type: news

TGF-{beta} receptor I/II trafficking and signaling at primary cilia are inhibited by ceramide to attenuate cell migration and tumor metastasis
Signaling by the transforming growth factor–β (TGF-β) receptors I and II (TβRI/II) and the primary cilia-localized sonic hedgehog (Shh) pathway promote cell migration and, consequently, tumor metastasis. In contrast, the sphingolipid ceramide inhibits cell proliferation and tumor metastasis. We investigated whether ceramide metabolism inhibited TβRI/II trafficking to primary cilia to attenuate cross-talk between TβRI/II and the Shh pathway. We found that ceramide synthase 4 (CerS4)–generated ceramide stabilized the association between TβRI and the inhibitory factor Smad7, which lim...
Source: Signal Transduction Knowledge Environment - October 24, 2017 Category: Science Authors: Gencer, S., Oleinik, N., Kim, J., Panneer Selvam, S., De Palma, R., Dany, M., Nganga, R., Thomas, R. J., Senkal, C. E., Howe, P. H., Ogretmen, B. Tags: STKE Research Articles Source Type: news

R3 Stem Cell Now Offering Amniotic Membrane Allograft for Effective...
Regenerative medicine company R3 Stem Cell is now offering amniotic membrane allograft for eye care treatment. The membranes are safe, effective, FDA regulated and excellent for all types of...(PRWeb October 23, 2017)Read the full story at http://www.prweb.com/releases/amnioticmembraneallograft/r3-stem-cell/prweb14831115.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 23, 2017 Category: Pharmaceuticals Source Type: news

NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures
New clearance for TLX™ system includes indications for use with allogeneic bone graft and in additional levels of the spine; Technology to be showcased at NASS 2017 SAN DIEGO, Oct. 16, 2017 -- (Healthcare Sales & Marketing Network) -- NuVasive, Inc. (N... Devices, Neurosurgery, Orthopaedic, FDA NuVasive, TLX interbody, TLIF, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 16, 2017 Category: Pharmaceuticals Source Type: news

FDA expands indication for NuVasive ’ s TLX spine implant
NuVasive Inc. (NSDQ:NUVA) said today the it won expanded 510(k) clearance from the FDA for its TLX implant used in spinal fusion surgery. San Diego-based NuVasive said the new clearance covers an new, expandable 20° cage and new indications for use covering allogeneic bone grafts and more spine levels. “With the additional clearance for our latest TLX system, we now provide the leading tools for [transforaminal lumbar interbody fusion] procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” strategy, technology & corporate development EVP Matt Link said in pr...
Source: Mass Device - October 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Spinal Nuvasive Source Type: news

Hamstring autograft with preserved insertions linked to improved outcomes compared to free autograft for ACL patients
A study published online in the journal Arthroscopy compares differences in short-term outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction using a graft with preserved insertions and those treated with a free hamstring graft.  (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - October 15, 2017 Category: Orthopaedics Tags: Featured Editors Choice News Source Type: news

Dr. Gloria Matthews Joins MiMedx As Its Senior Vice President Of Research And Development
MIMEDX REAFFIRMS LATEST THIRD QUARTER OF 2017 REVENUE EXPECTATIONS MARIETTA, Ga., Oct. 3, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative a... Devices, Regenerative Medicine, Personnel MiMedx Group, PURION, placental tissue allograft (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 3, 2017 Category: Pharmaceuticals Source Type: news

OSTEOPOROSIS: How weak bones could leave you inches shorter
WHEN Christine Howis broke her arm at the age of 51, she thought it was no more than an accident – even though she eventually needed a bone graft when it failed to heal properly. (Source: Daily Express - Health)
Source: Daily Express - Health - September 26, 2017 Category: Consumer Health News Source Type: news

Treatment of Large Bone Defect from Root Fracture
In this case, a large bone defect, as a consequence of fractured roots of the first molar, was augmented by Bond Apatite bone graft cement. (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - September 25, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Cases Regenerative Source Type: news

Tiny diamonds could become best friends to youths with cleft palates
This study showed that our method has a contained, targeted and sustained effect, so we’re very excited about it,” Hong said.Previous experiments showed nanodiamonds to be safe within the body and to be excreted normally. Similarly, earlier work demonstrated that enzymes break down hydrogel.The researchers plan to continue laboratory studies and hope to bring their treatment to clinical trials. Their approach has implications for treating other craniofacial conditions and sleep apnea, as well as healing wounds and bone injuries.Other authors of the study were Dong-Keun Lee, Lawrence Lin, Hsin Chuan Pan, Deborah...
Source: UCLA Newsroom: Health Sciences - September 22, 2017 Category: Universities & Medical Training Source Type: news

Will Small Companies See a Bigger Impact from Hurricanes?
Cardiovascular Systems Inc. said Monday that its procedure volumes took a hit in the Houston, TX, and Florida markets, which account for more than 15% of the company’s revenue, in the aftermath of Hurricanes Harvey and Irma. To add insult to injury, the company reported that September is normally its strongest month for procedures within the quarter, which means the fiscal first quarter revenues are more heavily weighted in September.  The company is based in St. Paul, MN, but has a facility in Pearland, TX, near Houston. "As recovery progresses, we will closely monitor conditions and the anticipated i...
Source: MDDI - September 19, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis Medical Device Business Source Type: news

MiMedx loses appeal in placental allograft tissue patent spat
A Federal Circuit Court this week affirmed a Patent Trial and Appeal Board ruling which found a MiMedx (NSDQ:MDXG) tissue graft patent invalid in a spat between the company and the Musculoskeletal Transplant Foundation. The ruling came from a 3-judge panel, delivered in a 1-line order without an opinion, affirming the PTAB’s decision from last month which found the patent as invalid as obvious, according to court documents. The spat is related to a dehydrated human amnion/chorion membrane placental tissue allograft patent, with Marietta, Ga.-based MiMedx claiming that the MTF infringed upon it with their own gra...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Legal News Patent Infringement MiMedx Group Inc. Source Type: news

MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles Tendonitis
MARIETTA, Ga., Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts ... Biopharmaceuticals, Regenerative Medicine, Orthopaedic, FDA MiMedx Group, AmnioFix, achilles tendonitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 7, 2017 Category: Pharmaceuticals Source Type: news

Never say never again: a bone graft infection due to a hornet sting, thirty-nine years after cranioplasty - Maugeri R, Giammalva RG, Graziano F, Basile L, Gul ì C, Giugno A, Iacopino DG.
BACKGROUND: Cranioplasty (CP) is a widespread surgical procedure aimed to restore skull integrity and physiological cerebral hemodynamics, to improve neurological functions and to protect the underlying brain after a life-saving decompressive craniectomy (... (Source: SafetyLit)
Source: SafetyLit - September 7, 2017 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 5, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. How medical device risk management is connected with design controls Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear. Intended us...
Source: Mass Device - September 5, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Medtronic launches long-term PLF, TLIF Infuse bone protein study
Medtronic (NYSE:MDT) said today it launched a long-term clinical study of its Infuse bone graft for use during posterolateral fusion and transforaminal lumbar interbody fusion spine procedures. The 1st patient in the study was enrolled at Indiana’s Fort Wayne Orthopedics and underwent a procedure led by Dr. Kevin Rahn and Dr. Robert Shugart, Fridley, Minn.-based Medtronic said. “Failed back surgery is a real concern with long-term implications, and successful outcomes in PLF and TLIF procedures require solid fusion. We believe there is significant data on the safety and efficacy profile of Infuse in approv...
Source: Mass Device - September 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Spinal Medtronic Source Type: news

Bone Binders for bone augmentation?
Do you know of any bone binders used in oral bone augmentation procedures that would not interfere with osteogenesis, resorb parallel with bone graft material and be biologically inert? (Source: Dental Implants Discussed by Experts)
Source: Dental Implants Discussed by Experts - August 30, 2017 Category: Dentistry Authors: osseonews Tags: Clinical Questions Regenerative Source Type: news

Metro Atlanta's MiMedx to spin out subsidiary to focus on biopharma
Marietta-based MiMedx Group, Inc. (NASDAQ: MDXG) has signed an agreement to divest the company's subsidiary, Stability Biologics LLC, back to its original stockholders. MiMedx's said its transition into a biopharmaceutical company was an impetus for this divestiture initiative. MiMedx Group is developing and marketing regenerative and therapeutic biologics with human placental tissue allografts and patent-protected processes for multiple sectors of health care. In January of 2016, the company acquired… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - August 21, 2017 Category: American Health Authors: Eric Mandel Source Type: news

MiMedx divests Stable Biologics subsidiary in transition to focus on biopharma
MiMedx (NSDQ:MDXG) said today it inked a definitive agreement with the former shareholders of Stability Inc. to divest itself of Stability Biologics, which it acquired last January. The Marietta, Ga.-based company said the divestiture is part of its plan to transition back into a biopharmaceutical-focused company. “The transaction is expected to be completed in the 3rd quarter of 2017, and the consideration will include a promissory note issued by Stability Biologics in the principal amount of $3.5 million in favor of MiMedx and a waiver by the former stockholders of Stability, Inc. ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Regenerative Medicine MiMedx Group Inc. Stability Biologics Source Type: news

Camber spine wins FDA nod for Spira interbody fusion device
Camber Spine Technologies said today it won FDA 510(k) clearance from the FDA for its Spira open matrix anterior lumbar interbody fusion device. The Wayne, Penn.-based company said the Spira device consists of spiral support arches designed to increase fusion rates and stabilization. The company said the spiral support arches also decrease subsidence by load sharing over the entire endplate while also maximizing bone graft capacity. “Camber Spine is very excited to be launching our first in a series of spinal implants using 3D printed – additive manufacturing. This specialized manufacturing technology allows us...
Source: Mass Device - August 16, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Spinal camberspine Source Type: news

Prolonged Allograft Survival in Chronic Immunosuppression Prolonged Allograft Survival in Chronic Immunosuppression
This review explores the potential for the indefinite survival of a skin allograft among transplant patients on chronic immunosuppression.Wounds (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - August 15, 2017 Category: Intensive Care Tags: General Surgery Journal Article Source Type: news

Pain and itch outcome trajectories differ among European American and African American survivors of major thermal burn injury
Over half of individuals experiencing major thermal burn injury (MThBI) receive an autologous skin graft (autograft), in which skin is removed from a healthy " donor " site and transplanted to the burn site. Persistent pain/itch at the graft site are major causes of suffering and disability in MThBI survivors. African Americans have a higher risk of MThBI, and in other clinical settings African Americans experience a greater burden of pain and itch relative to European Americans. However, to our knowledge, ethnic differences in skin graft site pain/itch outcomes after MThBI have not been assessed. We evaluated sk...
Source: Current Awareness Service for Health (CASH) - August 14, 2017 Category: Consumer Health News Source Type: news

7 medtech stories we missed this week: August 11, 2017
[Image from unsplash.com]From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally m...
Source: Mass Device - August 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Food & Drug Administration (FDA) Oncology Regulatory/Compliance Spinal Surgical Apifix Cardiac Science Hip Innovation Life Spine Inc. MedTech Pentax Medical Varian Medical Systems Xtant M Source Type: news

Immediate implant placement into posterior sockets with or without buccal bone dehiscence defects: A retrospective cohort study
ConclusionsWithin the limitations of this study, flapless implant placement into compromised sockets in combination with DBBM grafting may be a viable technique to reconstitute the defected buccal bone plates due to space maintenance and primary socket closure provided by healing abutments and bone grafts.Clinical significanceImmediate implants and DBBM grafting without using membranes may be indicated for sockets with buccal bone defects. (Source: Dental Technology Blog)
Source: Dental Technology Blog - August 4, 2017 Category: Dentistry Source Type: news