Tuesday, February 25, 2020

Biologics: Orthopedics: Bone Solutions Inc. Successfully Surpasses 1,000 Implanted Cases with OsteoCrete® Magnesium-Based Bone Void Filler

BoneSolutionsIncDALLASFeb. 25, 2020 /PRNewswire/ -- Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, TX, announces it has surpassed 1,000 cases implanting OsteoCrete®   in various orthopedic applications.
"The Company has now again reached a wonderful milestone. We have successfully implanted OsteoCrete® in over 1,000 cases throughout the United States in various hospitals and teaching institutions," says BSI president and CEO, Drew Diaz.
"OsteoCrete was introduced to me at a time when I was looking for a structural bone void filler that has resorption capabilities as well as prevents subsidence of reduction while having the properties to stimulate natural bone remodeling. It delivered on these expectations and much more. The handling properties and physical characteristics are second to none. I can inject, pack, mold, and even sculpt OsteoCrete to meet any bone void filling need that I encounter in a practice of complex fracture and trauma patients," states Robert J. Wetzel, MD Orthopedic trauma surgeon at University Hospitals Cleveland Medical Center and assistant professor at Case Western Reserve University.
OsteoCrete® contains magnesium and as a result, has a high compressive strength that is three times stronger than the average cancellous bone. Most of the magnesium in the body (60%) is stored in bone and helps to preserve and develop bone structure by working with Vitamin D and calcium. Its essential role in maintaining healthy bones was a key component of BSI's approach to developing its OsteoCrete® technology.
About Bone Solutions Inc.Bone Solutions Inc. ('BSI') (www.bonesolutions.net) is an orthobiologics company with a vision to provide orthopedic surgeons a means to improve clinical outcomes in a number of complex procedures while lowering costs. The company is revolutionizing a new solution for orthopedic surgeons for human uses with their FDA-cleared magnesium-based platform bone void filler.
Media Contact:
Bone Solutions Inc.:
Drew Diaz
817-809-8850, diaz@bonesolutions.net 
SOURCE Bone Solutions Inc. & PR Newswire

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Sunday, February 23, 2020

Device: Spine: Biomechanical Analysis of Inspan Spinous Process Fixation Alone in The Lumbar Spine Demonstrates Positive Results

Biomechanical studies of the Inspan device suggest it may be the strongest interspinous fixation device on the market and thus is being used for spinal fusion replacing the traditional method that uses pedicle screws and interbodies with laminectomies.
BOSTONFeb. 18, 2020 /PRNewswire-PRWeb/ -- INSPAN LLC (a privately-owned company) is pleased to announce the positive results from a biomechanical analysis of spinous process fixation alone or with facet screws in the lumbar spine using the Inspan interspinous fixation device (INSPAN LLC). Unlike the extension block design, the Inspan device fixates the spine to allow for immediate stability, distraction, decompression, and fusion. Biomechanical assessments of interspinous process fixation have demonstrated particularly advantageous outcomes in stabilizing the sagittal plane for during flexion and extension. Biomechanical studies of the Inspan device suggest it may be the strongest interspinous fixation device on the market and thus is being used for spinal fusion replacing the traditional method that uses pedicle screws and interbodies with laminectomies.

The study was performed at the LESS Institute by Professor Dr. Kingsley R Chin, MD, a board-certified orthopedic spine surgeon and coauthors Dr. Fabio Pencle and Dr. Jason Seale.
Human cadaveric spines were biomechanically tested under the following conditions: 1) intact/control; 2) Inspan only, 3) Inspan with facet screws (FS), 4) Inspan with lateral interbody fixation (LIF), 5) Inspan with LIF and FS. Each test consisted of 100 N of axial preload with ± 7.5 Nm of torque in flexion/extension (FE), right/left lateral bending (LB), and right/left axial rotation (AR).
The study showed a decrease in flexion-extension, lateral bending and axial bending in all conditions compared to intact control. Adding facet screws does not improve stability during flexion/extension (already best loading mode for spine process plating). With LIF, each point of fixation added (FS or Inspan) incrementally improves stability by about the same amount during lateral bending and axial rotation.
In conclusion, Inspan proved effective biomechanically in increasing foraminal height and restricting flexion/extension motion. Other effects without LIF, Inspan is moderately effective in restricting axial rotation or lateral bending. With the LIF interbody, testing showed better stability than no LIF. The addition of Inspan to lumbar fixation increases foraminal height by 1mm minimum.
INSPAN, LLC is privately owned by KICVentures and is focused on advancing the platform of patented interspinous fixation technology. The Inspan device has a proven ten-year track record with thousands implanted since FDA-clearance in 2010.
Inspan FDA Indications
The Inspan Slim Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture ordislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.
Original article published at PR Newswire and was republished by Yahoo Finance

Friday, February 21, 2020

Device: Spine: Genesys Spine is pleased to announce the launch of our Sacroiliac Joint Fusion System

Genesys SpineAUSTIN, TexasFeb. 20, 2020 /PRNewswire/ -- The Genesys Spine Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micro-motion enabling bony fusion.
Advantages of the Genesys Spine Sacroiliac Joint Fusion System include:
  • Dual thread designs incorporate a differential pitch for controlled compression across the joint.
  • Cannulated design allows for minimally invasive placement.
  • Offered in fully threaded and dual threaded configurations.
  • Optional washers designed to maximize purchase on the ilium without burying the implant head in the bone.
  • Increased surface roughness to help facilitate osteoinduction.
  • Rifled inner diameter to reduce inadvertent targeting pin migration.

"The Genesys Spine SI Fusion System is a game changer. It provides one streamlined system that addresses the pathology of sacroiliitis in both the lateral and posterior approaches. Many SI pain patients are mis/underdiagnosed due to their pain mimicking low back pain. This system will deliver health care providers with versatile tools to treat these patients in need of an SI Joint Fusion." - Dr. Kaywan Gamadia, DO Cape Spine & Neurosurgery Cape Girardeau, MO
SOURCE Genesys Spine
Original article published at PR Newswire 

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Thursday, February 20, 2020

News: Procedure: Brain surgery patient filmed playing violin during brain surgery

Dagmar Turner was woken up after her skull was removed and played the violin while surgeons removed her aggressive brain tumour.

A patient at King’s College Hospital in London has played the violin while surgeons operated on her brain to remove a tumour.
The medical team asked Dagmar Turner, 53, to play the violin to ensure parts of the brain which control delicate hand movements and coordination were not damaged during the millimeter-precise surgery.
Ms. Turner, a former management consultant from the Isle of Wight, was diagnosed in 2013 with a brain tumour after suffering a seizure during a symphony.
The committed violinist, who plays in Isle of Wight Symphony Orchestra, was worried the surgery would mean she would lose the ability to play.
Her tumour was located in the right frontal lobe of her brain, close to an area that controls the fine movement of her left hand.
Professor Keyoumars Ashkan, the consultant neurosurgeon at King’s College Hospital, came up with a plan to operate and reduce the risk.
The brain tumour specialist holds a degree in music and is an accomplished pianist and shared Ms. Turner’s desire to save her musical skills.
Prior to surgery, doctors spent two hours carefully mapping her brain to identify areas that were active when she played the violin and those responsible for controlling language and movement.
Surgeons performed a craniotomy and opened her skull, before waking her from the anesthetic.
Ms. Turner played violin while her tumour was removed, while closely monitored by the anaesthetists and a therapist.
Prof Ashkan said: “We managed to remove over 90 percent of the tumour, including all the areas suspicious of aggressive activity while retaining full function in her left hand.”
Ms Turner added: “The violin is my passion; I’ve been playing since I was 10 years old. The thought of losing my ability to play was heartbreaking.”
Three days after the procedure Ms. Turner was well enough to go home to her husband and son.
King’s College Hospital, in south London performs around 400 surgeries to remove brain tumours each year and often wake patients to carry out language tests.

Original posting at 

Wednesday, February 19, 2020

News: Policy: Spine: Should pain management physicians perform endoscopic spine surgery? 9 spine specialists discuss

Nine spine specialists debate which physicians should and should not be able to perform endoscopic spine surgery.
Ask Spine Surgeons is a weekly series of questions (published at Beckers Spine) posed to spine surgeons around the country about clinical, business and policy issues affecting spine care.
Note: The following responses were edited for length and clarity.
Question: What is your opinion on pain management physicians performing endoscopic spine surgeries?
Tony Mork, MD. Newport Beach (Calif.): My opinion is that pain management physicians could perform endoscopic procedures outside of the spinal canal with proper training and mentoring. Since so many pain generators/facets in the spine are located outside of the spinal canal, endoscopic spine surgery is synergistic with a pain management physician's scope of practice.
The endoscopic approach to pain offers society, government and the insurance industry a proven therapy to decrease the use of opioids, by 'curing' spine pain rather than managing it. For example, endoscopic techniques offer the low-risk possibility of a 'cure' of facet syndrome pain. There is not much a spine surgeon can offer for facet syndrome except a spinal fusion, which is too much treatment for the patient and too costly for payers and the government.    
Sensory nerves can be visualized directly with endoscopic surgery and divided. Because the nerve sheath is divided and not left intact, nerve division offers permanent relief as opposed to the temporary relief provided from radiofrequency. 
The pain management physician is usually the practitioner who confirms the diagnosis of facet syndrome with needle injections and is very familiar with the anatomy of the facets, so, therefore, is there really much difference between a 1 mm needle to diagnose the facet problem and a 7 mm endoscope to treat it definitively? Given the previously developed expertise with the 1 mm needle, I believe the pain management physician, if given the proper training, could successfully perform endoscopic procedures.
Issada Thongtrangan, MD. Microspine (Phoenix): This is a tough question. As a fellowship-trained spine surgeon who adopted this technology and has been doing more endoscopic spine surgery in the past 3-4 years, I can say that it's not easy. I feel that we must put the patient's best interest as the first priority. I would say it is OK for a well-trained pain management specialist to perform an endoscopic spine surgery if they can take care of the complications or have a well-trained spine surgeon scrub in the case. Another area is how well they can select the appropriate patients who have solid indications as most of the pain specialists are likely trained in the different aspects of spinal disorders.
Fred Naraghi, MD. Comprehensive Spine Center (Klamath Falls, Ore.): I don't think it's a good idea. Endoscopic spine surgery has a steep learning curve and may be associated with significant complications. Spine surgeons are better trained to treat the possible complications of endoscopic procedures. Ultimately, patient safety and improved outcome is the goal.

James Chappuis, MD. Spine Center Atlanta: Any physician who is well trained should be able to conduct procedures that they are trained in as long as they can handle the complications that could arise from that procedure. Currently, in our practice, endoscopic spine surgery is only performed by board-certified, fellowship-trained spine surgeons. This doesn't mean it will always be this way. This is just what I am comfortable with at this time for the best interests of our patients.

Brian Adams, MD. Spine Center Atlanta: As an interventional spine pain management physician, I am intrigued about the utilization of endoscopic surgery. Since this is largely an image-guided technique, I feel that it is a tool that can be safely incorporated into an advanced interventional spine practice. While I think there are certain limitations to what procedures are appropriate for an interventional physician, the most important consideration is a good symbiosis between interventionalist and surgeons. This is probably best utilized in a practice with both interventionalists and surgeons working together under one roof.
Noam Stadlan, MD. NorthShore University HealthSystem (Evanston, Ill.): The optimal care of spine patients requires the expertise of a number of specialists: surgeons, pain management specialists, physical and occupational therapists, pain psychologists, radiologists and more. Patients will benefit most when all specialists do what they do best and collaborate with others who have different areas of expertise.
Spine surgeons spend many hours during their residencies developing the experience and diagnostic skills to make the clinical diagnoses that are fundamental to the success of any treatment. Pain management physicians who are performing endoscopic surgeries are best served by working with spine surgeons who can provide expertise in the diagnosis and radiographic interpretation, as well as complication management when they occur. Performing these surgeries without the integration of spine surgeons in the decision-making process and postoperative management, when necessary, can result in less than optimal results.
Harel Deutsch, MD. Rush University (Chicago): While pain management physicians are billing for these procedures and want to get the higher valued codes, the procedures they do are not effective or equivalent to spine surgeries done by neurosurgeons and orthopedic surgeons.

Christian Zimmerman, MD. Saint Alphonsus Medical Group and SAHS Neuroscience Institute (Boise, Idaho): This topic begs the fundamental premise of training, ability, and accountability. My rebuttal is centered on complication management and one's ability to administer care in the likelihood of that situation arising. The actual dissent and friction of this extraneous practice surround the efficacy of such procedures, where both radiologists and surgeons alike, cannot measure or detect the actual surgical interventions of these 'surgical procedures' on CT or MRI scanning. The determinations for these procedures markedly exceed the indications, characterizing the process as deluding.  
Recently, a patient was seen in my office after having a 'decompressive' operation performed in a pain clinic where neither the symptoms were changed nor was there any radiological evidence of the surgery. This patient had been charged an additional fee on top of their insurance allowable making this procedure at its least derivative, a holistic failure, and financial overextension. Granted, the management of chronic pain is difficult and at times empirical. Adding to the empiricism with additional risk and fewer control mechanisms seems foolhardy at best.
Brian Gantwerker, MD. Craniospinal Center of Los Angeles: In general, I think if you cannot fix a complication from a procedure you are performing, you should not be doing it.

Tuesday, February 18, 2020

Device: Spine: Additive Implants Announces FDA Clearance for SureMAX™-X Cervical Spacer

PHOENIXFeb. 18, 2020 /PRNewswire/ -- Additive Implants, Inc. is pleased to announce it received regulatory clearance to market in the US its second product, the SureMAX™-X Cervical Spacer. This 3D printed titanium spacer has a unique patented* design to create uniform endplate coverage and optimize load distribution.

"Maximizing implant coverage of the endplates and providing for more uniform load distribution is important to minimizing implant subsidence. We accomplished this objective through a number of differentiated features on the spacer, including the posterior window and the eyebrow holes on the anterior surface," said Bob Brosnahan, COO of Additive Implants.
The roughened porous and convex shaped surfaces maximize contact with the bony endplates. Large lateral windows facilitate radiographic confirmation of healing.
SureMAX™-X offers an industry-leading range of implant sizes; 7º, 10º and 14º lordotic and hyperlordotic angles with footprints of 12 x 14mm, 14 x 16mm, 15 x 18mm, and 15 x 20mm in heights of 5, 6, 7, 8, and 9mm.
Brosnahan added, "By using Euler's Column Theory and limiting the implant's height to 9mm, we were able to make SureMAX™-X less stiff than other titanium spacers."
While in contrast, the SureMAX™ Cervical Spacer, Additive Implants' first product launch, is more focused on bone implant interface and overall stability.
"We felt it was important for us as a company to offer choices of not just sizes but also design philosophies," said Jeff Horn, VP Commercialization of Additive Implants. "We wanted surgeons to have multiple options to deliver the best surgical outcomes based on their technique preferences; whether they use Caspar pins, do bone sparing surgery or thoroughly debride the end plates."
For more information, contact Jeff Horn at Additive Implants at 3101 East Shea Boulevard, Suite 122; Phoenix, Arizona; 85028;www.AdditiveImplant.com; (602) 418-6003.
* US Patent #10,299,938 and other patents.
SOURCE Additive Implants, Inc.
Original publication at PR Newswire

Device: Spine - Tenon Medical, Inc. Releases the Results of the First Post-Clearance Clinical Study

SAN RAMON, Calif., Feb. 10, 2020 /PRNewswire/ -- 
Tenon Medical, Inc., a manufacturer of instruments and implants for sacroiliac joint fusion surgery, today announced the completion of the first phase of its post-approval clinical study for the Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ Fixation System) specifically indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. The company received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the device in the fall of 2018.
The results demonstrated greater than 85% reduction in SIJ pain at 6 weeks and radiographic evidence of the presence of solid continuous bridging bone across the treated joint at 6 months.  No procedure- or device-related serious adverse events were reported.
A unique feature of the CAT SIJ Fixation System procedure is the ability to directly visualize the joint allowing for a significant increase in reimbursement for the surgeon and facility payments.  "This single implant SIJ fusion system allows me to use either a navigated procedure or fluoroscopic imaging providing flexibility in access and visibility. The implant is designed to breach the SIJ and allow for bone graft materials to be loaded and delivered to the SIJ before and after implant placement to promote fusion of the SIJ. The unique trajectory eliminates the risk of sacral nerve root injury encountered with other fusion techniques and reduces the risk of entry into the retroperitoneal space.  By supplementing fixation with decortication and bone grafting, I can be confident that my patients have the best possible foundation for biological fusion, and long-term relief," said Dr. Michael Chaparro.

Image result for tenon medical

"Our unique approach is designed to drastically reduce procedure time and represents a landmark innovation for SIJ fusion surgery benefiting patients, surgeons, facilities, and payers," said Dr. Kal Mentak, CEO of Tenon Medical.

In November 2016, Tenon Medical, Inc. was granted the first US patent covering a novel posterior approach SIJ fusion system.  The company has since filed for additional compositions. 

Tenon Medical, Inc. is a privately held company located in the San Francisco Bay Area.
For inquiries about the CAT SIJ Fixation System, please contact Kal Mentak at  kmentak@tctig.com.

SOURCE Tenon Medical, Inc.