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It is the leading subspecialty journal for the treatment of spinal disorders.

If you have moderate degenerative LSS and conservative measures are not providing relief, there may not be a need to jump automatically to a surgical solution. References 1. However, the new results suggest that spacers carry a "substantially greater likelihood" of requiring further surgery later on.

They conclude, "Use of interspinous spacers poses a trade-off in outcomes: fewer complications for the index operation, but higher rates of subsequent lumbar surgery.".

Vertiflex, who sells Superion, wants to put the light on their device. Tendency to sit or lean over to relieve pain Learn about LSS and the Vertiflex Procedure. Spacers for Spinal Stenosis Have Lowest Complication Rate…The researchers compared the outcomes of three alternatives for surgical treatment of spinal stenosis in the lower (lumbar) spine. Event in Progress, Newswise For patients at average risk, "the higher reoperation rate with spacers may argue in favor of conventional decompression surgery," the researchers write. Vertiflex Procedure Lumbar Spinal Stenosis Treatment | Lumbar spinal stenosis (LSS) is a progressive narrowing of the spinal canal, commonly due to either facet and ligamentous hypertrophy and is often associated with degenerative spondylolisthesis, most commonly at L4-5.

Relevant fi nancial activities outside the submitted work: consultancy, grants pending, payment for lectures, royalties, payment for development of educational presentations, other, board membership, travel accommodations, stock. Stromqvist BH, Berg S, Gerdhem P, et al. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health. Dr Deyo and coauthors note some important limitations of their study—particularly the lack of data on pain relief or functional recovery. Made of titanium, the Vertiflex® interspinous spacer has … It is also a reasonable option for those who may not be good candidates for spine surgery. Patients with spinal stenosis have narrowing of the spinal canal, causing back pain, leg pain, and other symptoms. VertiFlex Inc. San Clemente, CA, funds were received in support of this work.

In many ways it treats a story – that of the person who … Less-Invasive Option for Spinal Stenosis Poses 'Trade-Off' in Outcomes, Reports Study in Spine.

Newswise — Philadelphia, Pa. (May 7, 2013) - Interspinous spacer implantation—a less-invasive alternative surgical option for spinal stenosis—has a lower complication rate than spinal fusion, reports a study in the May 1 issue of Spine. Aching, dull back pain spreading to legs. However, patients receiving interspinous spacers are more likely to require repeated back surgery, according to the report by Dr Ricard A. Deyo and colleagues of Oregon Health & Science University, Portland.

Lumbar Spinal Stenosis is caused by changes in the shape and size of the spinal canal as we age. The authors discuss the trade-offs among complications, costs, and repeat surgery. Live - It is placed delicately between the posterior aspects, or back part, of the spine.

Applicant’s Name and Address: VertiFlex ® ... Below is a list of potential adverse effects (e.g., complications) associated with use of the Superion ® ISS.

The spine undergoes many degenerative changes as a natural result of aging.

LWW is part of Wolters Kluwer Health, a leading global provider of information, business intelligence and point-of-care solutions for the healthcare industry.

"Hospital payments for spacer surgery were greater for decompression alone, but less than for fusion procedures," the researchers write.

However, the Vertiflex® interspinous spacer is a minimally invasive procedure that offers patients with LSS many distinct advantages. Vertiflex Superion is a new FDA approved procedure used to treat Lumbar Spinal Stenosis (LSS).

These complications may occur during or after placement of a coronary stent in your body .

It includes (1) … It provides patients with a clinically proven, minimally invasive solution that is designed to deliver long-term relief from the leg and back pain associated with LSS.

Of these, about 6,000 underwent implantation of interspinous spacers—small devices placed between vertebrae to control motion in the area affected by spinal stenosis.

Angina Pectoris— Symptoms experienced when the heart muscle is not receiving adequate oxygen (may include chest, arm or back pain, shortness of breath). The authors are biased simply by the way they hold their torch. They financially supported the authors of this paper. VertiFlex ® Superion® ... No major implant or procedure related complications o No dislodgement, migration, or deformation o New or persistent worsened neurological deficit at the index level o Spinous process fractures o Deep infection, death, or other permanent device attributed disability No clinically significant confounding treatments: o No epidural injections or nerve block procedures at index level, … However, some symptoms may actually be associated with a condition called lumbar spinal stenosis (LSS). Because it is a minimally-invasive procedure, the Vertiflex procedure is a solution for back pain patients for whom medications or injections have failed. “We are pleased with Panel’s support for PMA approval based on their thorough analysis of the level one evidence in our Superion IDE (investigational device exemption) trial. Wolters Kluwer Health is part of Wolters Kluwer, a market-leading global information services company with 2012 annual revenues of €3.6 billion ($4.6 billion).

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This level-one evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. • Air bubble in artery • Artery blockage or closure caused by stent • Artery spasm • Bleeding that would require a blood transfusion • Blood clot in artery • Damage to heart due to reduced oxygen • Death • Emergency bypass surgery • Heart attack • High or low blood pressure • Improper stent placement • Infection or pain at …

The device is placed rather simply. Event in Directions for Use Patient …

About Lippincott Williams & Wilkins Lippincott Williams & Wilkins (LWW) is a leading international publisher of trusted content delivered in innovative ways to practitioners, professionals and students to learn new skills, stay current on their practice, and make important decisions to improve patient care and clinical outcomes. 265 Turkey Sag Trail, Suite 102, #110, Palmyra VA 22963, Newswise

Superion Indirect Decompression System. The results, published in the Journal of Pain Research, showed an 85% decrease in the proportion of patients who were using opioids five years after being treated with interspinous process … The Vertiflex Procedure is redefining the treatment of LSS for patients. Spacers for Spinal Stenosis Have Lowest Complication Rate…The researchers compared the outcomes of three alternatives for surgical treatment of spinal stenosis in the lower (lumbar) spine. Despite the fact that they are composed of a wide range of different materials including titanium, polyetheretherketone, and elastomeric compounds, the aim of these devices is to unload spine, restoring foraminal height, and stabilize the spine by distracting the spi…

Within two years, about 17 percent of patients receiving spacers needed an additional operation on the lumbar spine, compared to 8.5 percent in the laminectomy group and about 10 percent in the fusion group.

Patients receiving spacers alone also spent less time in the hospital: average 1.4 days versus 2.7 days in the decompression group.

According to the latest ISI Science Citation Impact Factor, Spine is the most frequently cited spinal deformity journal among general orthopaedic journals and subspecialty titles. Numbness or tingling in the legs, buttocks, or back.

A large number of interspinous process devices (IPD) have been recently introduced to the lumbar spine market as an alternative to conventional decompressive surgery in managing symptomatic lumbar spinal pathology, especially in the older population.

…But Higher Rate of Repeated Spinal Surgery"Although patients receiving spacers had the lowest rate of complications, they had the highest rate of revision surgery," Dr Deyo and coauthors write. VertiFlex President and CEO Earl Fender said the panel "voted strongly” in support of the company’s pre-market approval application (PMA)." Patients receiving spacers tended to be older and to have other medical problems. Vertiflex Superion is a new procedure developed to treat spinal stenosis. This natural degenerative process can cause anatomical changes at any time but is most common in people over 50 years and may continue to progress with age. X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up.

They highlight the need for further research, including studies comparing the cost=effectiveness of spacers versus other options. Progress. Vertiflex has announced additional results from a randomised, controlled trial of its Superion Indirect Decompression System in patients with lumbar spinal stenosis (LSS). Also known as percutaneous transluminal coronary angioplasty (PTCA).

Unlike a … VertiFlex ® Superion® ... No major implant or procedure related complications o No dislodgement, migration, or deformation o New or persistent worsened neurological deficit at the index level o Spinous process fractures o Deep infection, death, or other permanent device attributed disability No clinically significant confounding treatments: o No epidural injections or nerve block procedures at index level, … It prevents extension of the spine while still allowing flexion. The Vertiflex Superion® interspinous spacer is a FDA-approved system designed to relieve back pain by restoring the normal space between the vertebrae. The benefit of that is, flexion of the spine opens the spaces and allows the pain to be resolved, whereas extension of the spine compresses, and that’s …

Since spacer implantation is less-invasive, it's not surprising to learn that it has a lower complication than more extensive surgical procedures. This listing was derived from results of the Superion® ISS clinical trial conducted under Investigational Device Exemption (IDE) #G070118, approved device labeling for other interspinous devices, and published clinical literature.

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The results showed that patients treated with spacers only had the lowest rate of major medical complications: 1.2 percent, compared to 1.8 percent with decompression and 3.3 percent with spinal fusion. Angioplasty— A minimally invasive treatment of the coronary arteries to open blocked arterial vessels. Live - I am grateful for our dedicated team of …

However, no studies have directly compared the outcomes of interspinous spacers with other surgical procedures for spinal stenosis.

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