IRVINE, Calif., Oct. 4, 2016 /PRNewswire-iReach/ — joimax^®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, will again exhibit at Eurospine 2016 taking place from October 5 – 7 in Berlin. During the conference, joimax^®will launch two new products – the MultiZYTE^® SI Endoscopic Sacroiliac Joint Therapy Set and its new Intracs^® Interaoperative Navigation Tracking & Control System.

MultiZYTE^® SI Endoscopic Sacroiliac Joint Therapy is developed for the treatment of the Sacroiliac Joint Syndrome (SIJS), which has been rediscovered as a major back pain generator in recent years. This kind of pain is commonly felt in the lower back, the gluteal region, the hip and thigh and can even radiate into the leg and foot. Until the 1930s, SI-Joint was the main reason for low back pain, but since 1934 the focus has been on disc herniation. According to recent studies, 15 to 25% of all low back pain is caused by the SI-Joint and up to 43% in patients having undergone lumbosacral fusion. MultiZYTE^® SI joimax^® now offers a well developed and lasting treatment option for this disease.

The Intracs^® Interaoperative Navigation Tracking & Control System was developed in cooperation between joimax^® GmbH Karlsruhe and fiagon GmbH in Berlin, both located in Germany. With the Intracs^® system, joimax^® instruments can be navigated directly at the tip using Fiagons “chip at the tip” technology which allows tracking of instruments with a diameter in the 1mm range. The Intracs ^® Navigation and Monitor Unit is integrated in the joimax^® Endoscopic Tower and all necessary tools are tailored for the TESSYS^® (transforaminal) and iLESSYS^® (interlaminar) procedures as well as for minimally invasive stabilization procedures, like EndoLIF^® and Percusys^®. The main features of the Intracs^® system are needle navigation through Vector-Tip-Target processing tools, the merging of 2D X-Rays with 3D- images of a patient’s CT or MRI scans, and the constant orientation control of any endoscope used in joimax procedures.

“With these two new developments we are in the position to enhance our endoscopic minimally-invasive product portfolio, driving adoption rates to meet new heights. With the world unique Intracs^® system, navigation is now faster, safer and more accurate than ever before using an electromagnetic (EM) field. Radiation exposure for both, patients and surgeons will be significantly reduced,” says Wolfgang Ries, CEO and founder of joimax^®.  “Additionally the learning curve for all spinal endoscopic procedures offered by joimax^® will now be significantly reduced and the rapid expansion of all these techniques is now well layed-out,” he continues.

About joimax^®

Founded in Karlsruhe, Germany, in 2001, joimax^® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS^® (transforaminal), iLESSYS^® (interlaminar) and CESSYS^® (cervical) for decompression procedures, MultiZYTE^® RT (e.g. for rhizotomy) and with MultiZYTE^® SI for SI-Joint therapy or with EndoLIF^®and Percusys^® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax^® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”). For more information visit www.joimax.com

Media Contact: Melissa Brumley, joimax® Inc., 001 949 859 3472, Melissa.brumley@joimaxusa.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE joimax

October 04, 2016

ALTSTAETTEN, Switzerland, September 29, 2016 /PRNewswire/ —

icotec AG, an innovative medical device company leading the industry in the development and manufacturing of non-metallic Carbon/PEEK composite medical devices, announces the brand name of BlackArmor^® for its Carbon/PEEK material, which boosts a 15 year and 20,000 implantation clinical track record in spinal and fracture surgical care.

BlackArmor is a combination of continuous, high-strength carbon fiber reinforced PEEK and the company’s composite flow moulding (CFM) process. The result is a medical device with an interwoven 3D fiber architecture that provides unmatched strength and endurance. icotec’s technology is an enabler for complex designs such as pedicle screws, vertebral body replacement devices or supplemental fixations devices, like anatomical bone plates. The combination of mechanical strength and non-metallic properties make BlackArmor also ideally suited for the treatment of spinal tumors.

In the case of spinal tumors, radiation therapy plays an important role in pain management and local tumor control after the surgical removal of the tumor and stabilization of the spinal column.

Before administering radiation therapy, the radiologist relies on accurate CT images to plan the radiation dose. However, the presence of metal spinal implants causes significant artifact on the planning images. This artifact makes it more difficult to delineate anatomic structures during radiation therapy planning and correctly calculate the proper dose distributions.

During radiation therapy, metal spinal implants may also shield tumor cells from the curing radiation. In addition, metal components induce scattering of the radiation beams into the surrounding soft tissue potentially causing side effects.  In some cases, patients may not be candidates for proton radiation therapy because of the presence of metal implants.

BlackArmor is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts; a significant clinical benefit in the postoperative monitoring of anatomical structures. In addition, the non-metallic nature of the BlackArmor material minimizes the risk for patients where metal allergies are a potential concern.

Orthopedic implants manufactured from BlackArmor Carbon/PEEK material were approved for CE-mark in 2000 and received FDA clearance in 2005.

About icotec

Founded in 1999, icotec AG has become a worldwide leader in the design, development and manufacturing of Carbon/PEEK composite to create high strength implants for loadbearing musculoskeletal applications. The company is headquartered in Altstaetten, Switzerland.

For further information, please contact info@icotec.ch, +41-717570000 or visit the websitehttp://www.icotec.ch/en/innovation/carbon-peek/

SOURCE icotec

SANTA ROSA, Calif., Sept. 29, 2016 /PRNewswire/ — Osseon is pleased to announce the addition of medical device industry veterans Eric Gilbert as VP of Sales, and Paul Rogan as Area Sales Manager. Mr. Gilbert and Mr. Rogan will join the existing Sales Management team as the company continues to expand its market share.

In response to the company’s rapid growth, Osseon has also implemented cutting-edge cloud-based systems for both customer relationship management and product training. In addition, Osseon continues to partner with a number of physicians, both in the U.S. and abroad, to publish a series of best practices white papers related to the diagnosis and treatment options for Vertebral Compression Fractures.

Osseon will be exhibiting their complete line of Vertebral Compression Fracture treatment products at the North American Spine Society Annual Meeting (NASS) in Boston, October 26-29, 2016, Booth #725.

About Osseon:

Osseon^® LLC is a private medical device company located in Santa Rosa, CA. Osseon is driven by the needs of patients and the physicians and health care providers who treat them. The company designs, manufactures and distributes innovative products to improve the quality of life for patients with vertebral compression fractures (VCF). Vertebral compression fractures may result from osteoporosis, osteotraumatic injuries, myelomas or other degenerative bone diseases.

For more information, visit osseon.com. Osseon^® is a registered trademark of Osseon LLC.

SOURCE Osseon LLC

Related Links

http://www.osseon.com

SAN JOSE, Calif., Sept. 28, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield (BCBS) of Nebraska has updated its medical policy to provide coverage for minimally invasive SI joint fusion using CPT 27279.  BCBS of Nebraska becomes the second BCBS plan following Michigan to establish a positive coverage policy for MIS SI joint fusion.  The new policy is based on a review of published clinical literature available as of March, 2016 and states: “fusion/stabilization of the sacroiliac joint for the treatment of back pain is scientifically validated when the patient has had a positive result with dual diagnostic blocks using 2 anesthetic agents with different duration of action and has tried and failed therapeutic injections and has tried and failed 12 weeks of conservative management which must consist of documented physical therapy and nonsteroidal anti-inflammatory medications.”

References cited within the new coverage policy consisted of published studies specific to iFuse^1,2.  iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed positive publications.  No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication citing clinical studies that demonstrate improved pain, patient function and quality of life.

“BCBS of Nebraska joins BCBS of Michigan along with a growing list of leading edge private insurers as well as Medicare nationwide to provide coverage for iFuse.  This positive coverage decision provides access to appropriate care for Blue Cross Blue Shield members throughout Nebraska who have been suffering with chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.

“I see patients in my practice on a regular basis who have suffered from chronic sacroiliac joint dysfunction for years and no longer respond to non-surgical treatment.  Many of these patients are surgical candidates,” said John Hain, MD at Nebraska Spine Hospital in Omaha, Nebraska.  “I am pleased that I can now offer my BCBS Nebraska patients the only minimally invasive procedure supported by two year outcomes data and give them a chance to have a better quality of life.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company develops, manufactures and markets minimally invasive products for the SI joint.  SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion.  iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

(DANBURY, CT ) – September 9, 2016 – Every year, 31 million Americans grumble “Oh my aching back”. Low back pain can range from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. Pinpointing the source of the pain and proper treatment is complicated enough, but what if the pain isn’t really caused by a problem with the spine?
Dr. David A. Bomback, a Spine and Scoliosis Surgeon with Connecticut Neck and Back Specialists, LLC in Danbury and performs surgery at Danbury Hospital, is helping patients find relief by treating a little known condition called sacroiliac joint dysfunction. Dr. Bomback is the first surgeon at Danbury Hospital to treat the condition with a sacroiliac joint fusion procedure and one of only a few surgeons in the entire state.

Where is the sacroiliac joint?
The sacroiliac joint connects the sacrum, the lowest bony segment of the spine, with the pelvis. The sacroiliac joint transmits most of the load from the upper body to the lower limbs, acting as a shock absorber in relieving forces on the spine. The joint is reinforced and supported by very strong ligaments. Occasionally, these ligaments can become too loose or too stiff so that the joint itself becomes arthritic, leading to persistent pain.
What causes sacroiliac joint dysfunction?
Sacroiliac issues are most commonly seen in mothers who have ligament loosening due to pregnancy, patients who have suffered trauma from an injury or accident, patients with certain arthritic conditions, and patients with previous lower back surgery (especially previous lumbar fusions). Approximately 25% of patients who visit spine surgeons actually have sacroiliac pain as that cause of his or her back pain rather than true lumbar (lower back pain).

Tough to Diagnose
Unfortunately, most tests including MRIs, x-rays, and CAT scans do not detect sacroiliac joint dysfunction, making the diagnosis challenging. “The diagnosis is truly made by sitting down and talking to the patient and getting an appropriate history, as well as a physical exam consistent with sacroiliac joint dysfunction,” explains Dr. Bomback. “When I examine a patient with sacroiliac pain, I stress the sacroiliac joint in a number of ways to see if I can elicit and/or reproduce the patient’s pain.”
Common Causes of Back Pain
The vast majority of low back pain is mechanical in nature, meaning damage to a vertebra of the lower spine. In many cases, it is caused by general degeneration of the spine associated with normal wear and tear that occurs in the joints, discs, and bones of the spine as people get older. Sprains, strains and traumatic injury are also contributors.
According to the National Institute of Neurological Disorders and Stroke, about 80% of adults experience low back pain at some point in their lifetimes. It is the most common cause of job-related disability and a leading contributor to missed work days. About 20% of back pain sufferers develop chronic pain with persistent symptoms lasting over one year. In some cases, treatment successfully relieves chronic pain, but in other cases pain persists despite medical and surgical treatment.
“Spinal surgeries at times can have a poor outcome if the diagnosis is made prematurely or incorrectly,” notes Dr. Bomback. “It is critical that the diagnosis of sacroiliac dysfunction is made appropriately, often times after diagnostic injections.”

The nuts and bolts of sacroiliac joint fusion surgery

The surgery involves a minimally invasive approach, placing three screws across the sacroiliac joint, bridging the spine to the pelvis to eliminate any abnormal motion thus allowing the joint to fuse over time. The surgery significantly reduces and oftentimes completely relieves the pain. An incision less than 1 inch in size is made through a tiny tube guided by a live x-ray. The surgery takes approximately 30 minutes and there is minimal and often no blood loss. The patient can usually go home the same day or occasionally after a one night hospital stay.

“The procedure has been around for approximately five to seven years,” said Dr. Bomback. “To date, approximately 19,000 patients have had the surgery in this country. We feel it is likely a permanent solution to the cause of their lower back pain and therefore offers an improvement in their quality of life.”

For more information on sacroiliac joint fusion surgery or to learn if you are a candidate for the procedure, please call 203-744-9700 or visit www.ctneckandback.com.

About Western Connecticut Health Network
Western Connecticut Health Network (WCHN) is the region’s premier, patient-centred health care organization built for the people we serve in Western Connecticut and adjacent New York. WCHN is anchored by three nationally recognized hospitals, Danbury Hospital, New Milford Hospital and Norwalk, with the continuum of outpatient health and wellness services offered by numerous medical practices and sub-specialties across the region through the Western Connecticut Medical Group, the Western Connecticut Home Care. Committed to learning and innovation, our hospitals collaborate with the University of Vermont Medical College and many other well-known academic institutions to promote the most progressive care possible. The nationally renowned WCHN Research Institute, the WCHN Foundation and Norwalk Hospital Foundation and other affiliates complete the WCHN family where We Know You Well! For more information, visit TheNewWCHN.org. Share your comments with us at Facebook.com/DanburyHospital; Facebook.com/NewMilfordHospital and/orFacebook.com/NorwalkHospital