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February 2-4, 2017
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RegulatorySpineTop Stories

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

March 29, 2017 OrthoSpineNews

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience.

Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company’s flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency.

“Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business,” said Jeff Smith, CEO of Providence Medical Technology.  “With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions.”

The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved.

Providence Medical Technology’s family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company’s focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients.

For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.

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RegulatorySpine

NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels

March 29, 2017 OrthoSpineNews

SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

Cervical radiculopathy and myelopathy secondary to cervical degenerative discs are common diagnoses in adult patients and have been shown to cause significant disability and loss of productivity.1 As a result of this common condition, more than 200,000 cervical surgical procedures are performed in the U.S. per year.2

“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” said Jason Hannon, NuVasive’s president and chief operating officer. “This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”

The NuVasive CoRoent Small Interbody System is an interbody cage manufactured from PEEK-Optima that provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy or tantalum.

The implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC).

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1Grasso G: Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disease. Eur Spine J 2015;24(Suppl 7):S842-8.
2American Associated of Neurological Surgeons. Artificial cervical disc surgery. [AANS web site]. May 2016. Available at: http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/-Artificial%20Cervical%20Disc.aspx. Accessed March 27, 2017.

 

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com, Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

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NeuroRegulatoryTop Stories

SafeOp Surgical Files for Ninth Patent

March 28, 2017 OrthoSpineNews

March 27, 2017

HUNT VALLEY, Md.–(BUSINESS WIRE)–SafeOp Surgical, Inc. (“SafeOp”), a privately held medical device company, today announced that it has filed its ninth patent application for innovations surrounding the monitoring of somatosensory-evoked potentials during surgeries. SafeOp developed and markets the EPAD™ system, a revolutionary neuromonitoring system that enables the detection of nerve damage and post-operative residual paralysis during surgical procedures. This latest filing is for the capability to reduce false positive alerts to nerve damage during surgeries. The company already holds patents for detection of nerve injury in the United States, Australia, Japan and China, and has several patents pending that include signal processing and high specificity in alerting to signal change, and on neuromuscular junction testing and spinal cord stimulator paddle placement.

“Electrical noise from nearby equipment often causes false alerts that are time consuming to deal with,” said Richard O’Brien, MD, MBA, SafeOp’s vice president of development and chief medical officer. “This new patent provides a method to condition the monitored responses and calculate an alert so that the likelihood of a false positive from a noisy signal is dramatically reduced while preserving the sensitivity of the monitoring to real changes.”

SafeOp’s EPAD™ system, which allows monitoring of both the spinal cord and peripheral nerves, was developed specifically for the rapid detection of perioperative nerve injury (“PNI”). PNI is a frequent complication of some surgeries (e.g., orthopedic, general, cardiac, or urological surgery), whereby peripheral nerves may be damaged due to unrecognized extended compression or stretching, or compromise of their blood supply. The EPAD™ system also allows easy-to-use quantitative monitoring of the neuromuscular junction to help detect another frequent complication, post-operative residual paralysis. This may occur when paralyzing agents have not sufficiently worn off at the end of surgery. The EPAD™ system provides real-time feedback, allowing caregivers to adjust the patient’s position in time to avoid nerve injury, or intervene when residual paralysis is present.

“We continue to innovate our EPAD™ system technology with powerful capabilities that will make it the most cost-effective intraoperative monitoring solution available,” said Gene Cattarina, SafeOp’s president and chief executive officer. “With its unique ability to economically and efficiently acquire somatosensory-evoked potentials, the EPAD™ is appropriate for all types of surgeries and an ideal low cost alternative to expensive insourced- and outsourced-driven neuromonitoring for certain spine and other surgeries.”

About SafeOp Surgical, Inc.

SafeOp Surgical, Inc. is a Hunt Valley, MD-based medical device company that has developed the FDA-approved EPAD™ system. The EPAD™ system enables simple-to-use neurological monitoring in a wide array of surgical procedures where full monitoring – which requires the continuous presence of a technologist and neurologist – may not be indicated, cost-effective or feasible. SafeOp currently markets the EPAD™ system to medical centers throughout the United States. For more information, visit SafeOp’s website at www.safeopsurgical.com.

Contacts

SafeOp Surgical, Inc.
Chris Brown, 410-773-9601
Cell: 214-213-9379
cbrown@safeopsurgical.com

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RegulatorySpineTop Stories

Altus Spine announces Silverstone Titanium FDA 510(k) Clearance

March 28, 2017 OrthoSpineNews

West Chester PA, March 17, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the FDA clearance of the Silverstone Titanium Interbody Fusion (IBF) System.  The Silverstone Titanium IBF System is designed to be implanted in the lumbar spine to aid in the stability and support of vertebral bodies during fusion.

The Silverstone Titanium IBF System is a simple, yet comprehensive, system that includes both PLIF and TLIF implants, and supporting instrumentation.  Introducing Altus Spine’s MicroLOC™ technology, the Silverstone Titanium IBF System incorporates the latest combination of macro- and micro-endplate surface texture design.  MicroLOC™ surface technology results in a proprietary, porous grip surface intended to provide an optimal environment for initial bone growth while minimizing the potential for implant migration.

“The development of MicroLOC™ surface technology was in response to surgeon requests for implant surfaces that encourage better on-growth of bone,” says Michael Fitzgerald, CEO and President of Altus Spine.  “The Silverstone Titanium implant is the first implant to employ MicroLOC™ surface technology.  The combination of easy implant insertion with the MicroLOC™ porous surface results in a state-of-the-art IBF implant.”

The Silverstone Titanium IBF System was created through the concentrated efforts of surgeons, engineers, and machinists to deliver the most advanced and cost effective implant system possible.  Its release closely follows last month’s market release of the Fuji Cervical Plate System.

Indications

The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients should have had six months of non-operative treatment.  These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Altus Spine

Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices.  Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field.  Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world.  For additional information, and to inquire about distribution opportunities , please visit www.altus-spine.com

Forward Looking Statements

All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions.  These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected.  These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases.  All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA).  Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements.  Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.

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RegulatoryTop Stories

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

March 23, 2017 OrthoSpineNews

March 20, 2017 by Stewart Eisenhart

EMERGO SUMMARY OF KEY POINTS:

  • The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018.
  • Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted.
  • Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry.

President Trump’s recently released budget blueprint for 2018 would adjust FDA user fees for 2018 to more than $2 billion, “approximately $1 billion over the 2017 annualized…level, and replaces the need for new budget authority to cover pre-market review costs.” These increases would be offset by administrative initiatives to boost regulatory efficiencies and speed up market authorization timeframes, according to the text of the proposed budget.

 

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Regulatory

Bergen County, New Jersey, Doctor Charged With Taking Bribes

March 23, 2017 OrthoSpineNews

Dept. Of Justice U.S. Attorney’s Office, District of New Jersey – March 8, 2017

NEWARK, N.J. – A family doctor practicing in Bergen County, New Jersey, was charged today with accepting bribes in exchange for test referrals as part of a long-running and elaborate scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, New Jersey, its president and numerous associates, U.S. Attorney Paul J. Fishman announced.

Bernard Greenspan, 78, of Saddlebrook, New Jersey, was indicted by a federal grand jury in Newark. The 10-count indictment charges Greenspan with one count of conspiring to commit violations of the Anti-Kickback Statute, the Federal Travel Act and wire fraud; three substantive violations of the Anti-Kickback Statute; three substantive violations of the Federal Travel Act; and three substantive violations of wire fraud. Greenspan will be arraigned at a later date.

“The charges contained in the indictment allege an extremely lucrative pattern of soliciting and accepting illegal payments for referrals to a specific testing lab,” said U.S. Attorney Fishman. “This indictment is part of our continued commitment to prosecute those physicians who sought to enrich themselves through their involvement in the BLS bribery scheme.”

“The FBI, in conjunction with our law enforcement partners, the U.S. Department of Health and Human Services’ Office of Inspector General, the Internal Revenue Service, and the U.S. Postal Inspection Service, will continue to investigate allegations of fraud and kickback schemes that undermine the integrity of our health care system,” stated Acting Special Agent in Charge Andrew Campi. “We urge anyone aware of this type of illegal activity to contact the FBI.”

“This indictment is another reminder that kickbacks in connection with federal health care programs are illegal and unacceptable,” said Scott J. Lampert, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services. “Taking such payments subverts the notion that patients should come before profits.”

 

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RegulatoryTop Stories

Dr. Price Brakes Bundled Payments Expansion

March 22, 2017 OrthoSpineNews

Walter Eisner • Tue, March 21st, 2017

Our orthopedic surgeon and Health and Human Services Secretary, Tom Price, M.D., has said he is no fan of bundled payments.

After just taking office in February, he’s already putting on the brakes to the payment model with the March 20, 2017 announcement that the expansion of hip and knee replacement bundled payment programs (Comprehensive Care for Joint Replacement – CJR) from the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center will be delayed.

Last fall, then Congressman Price, said in a letter to the Obama administration that CMS had overstepped its authority, upsetting the balance between the executive and legislative branches and failing to engage stakeholders when creating the programs. He also wrote, “these mandatory models overhaul major payment systems, commandeer clinical decisionmaking and dramatically alter the delivery of care.”

According to a March 20 notice in the Federal Register, the CJR program was scheduled to expand on the 20th, but those expansions will now be delayed until May 20, 2017 to “allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment [on] rulemaking to modify the policy if policy modifications are warranted,” and to make sure its participants understand the rules and how to comply with them.

 

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Regulatory

Obamacare Replacement Will Permanently Remove Medical Device Tax

March 21, 2017 OrthoSpineNews

By Jof Enriquez – March 9, 2017

Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.

The device tax has been suspended since December 2015, but GOP lawmakers and industry lobbyists have been pushing for a permanent repeal of a tax that they claim is detrimental to U.S. medtech innovation, as well as a jobs killer. A House of Representatives bill seeking to fully repeal the tax was filed in January.

Unveiled this week, the replacement of Obamacare known as the American Health Care Act (AHCA), will likely achieve the full repeal, beginning Jan. 1, 2018, according to RAPS.

The bill would repeal nearly all Obamacare taxes that would have cost health insurance firms, medical device makers, and other healthcare companies tens of billions of dollars over the next decade, reports The Washington Post.

 

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ExtremitiesRegulatory

First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line

March 16, 2017 OrthoSpineNews

LOGAN, Utah, March 15, 2017 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Staple™ System product family.

Previously, the company received clearance for its “Standard” size implants in different lengths, manufactured from titanium alloy. The new FDA clearance includes: “Standard” size implants manufactured from PEEK, “Small” size implants manufactured from titanium alloy or PEEK, and “Mini” size implants manufactured from titanium alloy. Standard size implants are well suited for hindfoot fusions and first tarsometatarsal joint fusions. Small size implants are well suited for midfoot fusions, first metatarsophalangeal fusions and carpal fusions. Mini size implants are well suited for carpometacarpal joint fusions, lesser metatarsophalangeal fusions, and fixation of Akin osteotomies. Surgeons now have the choice for radiopaque and, for the Standard and Small sizes, radiolucent implants.

The Stealth Staple™ System, an intraosseous small bone fixation system, represents a significant advancement for the treatment of arthrodesis, osteotomies and bone fractures. Current standard-of-care devices used to treat these indications are primarily bone plates and bone screws, or bone staples. Due to the prominence above the bone surface associated with these standard-of-care devices, there are notable clinical rates of device related pain, soft tissue irritation, and second surgeries for hardware removal. Since the Stealth Staple™ is completely contained within the bone upon implantation, clinical complications related to prominent hardware may be substantially reduced.

Another significant advancement provided by the Stealth Staple™ is the creation of controlled and evenly distributed compression across the opposing bone surfaces of an osteotomy or fracture. Finite element analysis and biomechanical testing have demonstrated superior strength, superior bone compression and superior resistance to gap formation compared to bone plate and screw systems (data on file).

First Ray is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Lane Hale
Executive Vice President
150433@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE First Ray

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Regulatory

Medtronic Announces New Bone Cement Indication for Treating Sacral Fractures

March 15, 2017 OrthoSpineNews

DUBLIN – March 14, 2017 – Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon(TM) Xpede Bone Cement for fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty – expanding the product’s indications beyond treatment of vertebral fractures due to osteoporosis, cancer or benign lesions.

Sacral insufficiency fractures (SIFs) are a common cause of debilitating lower back pain in the elderly, with incidence ranging from 1 to 5 percent in at-risk populations.1,2 According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis and low bone mass, placing them at increased risk for a fracture. Breaking a bone is a serious complication of osteoporosis, especially with older patients. Osteoporotic bone breaks are most likely to occur in the hip, spine or wrist, but other bones can break, too – including the sacrum.3

“Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them,” said Dr. Douglas Beall, chief of Radiology Services at Clinical Radiology of Oklahoma. “Having this new indication with Kyphon Xpede Bone Cement to use in the treatment of sacral fractures will help to address this patient population.”

A recent multi-center retrospective study of 243 patients with osteoporotic SIFs treated with sacroplasty reported significant pain relief for patients immediately following the procedure and after one-year follow-up; authors indicated that there were no major complications or procedure related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4 percent) having symptomatic leakage requiring decompression.2

“We are pleased to expand our therapies for interventional physicians treating osteoporotic patients to include those suffering from sacral insufficiency fractures,” said Jeff Cambra, general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “As the pioneers in balloon kyphoplasty for treating vertebral compression fractures, this expanded indication for Kyphon Xpede Bone Cement demonstrates our long-term commitment to continuously innovate and empower physicians to deliver the best clinical solutions to their patients.”

Kyphon Xpede Bone Cement is a quick-to-dough bone cement that provides ease of handling and allows sufficient time for careful, minimally invasive use. When paired with the Kyphon(TM) Cement Delivery System, clinicians can minimize their radiation exposure by standing up to four feet away from the radiation source during injection, which has been measured to reduce hand radiation exposure by 70 percent.4

About Sacral Insufficiency Fractures
Sacral insufficiency fractures (SIFs) are a common cause of debilitating back pain. SIFs mimic the symptoms of lumbar spine pathology and are commonly missed or underdiagnosed. Since the sacral ala is composed predominantly of cancellous bone – the first to be reduced in cases of osteoporosis and other metabolic conditions – it remains the most common region for SIFs.1,2

About Kyphon Xpede Bone Cement
Kyphon Xpede Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:

  • Cardiac arrest
  • Cerebrovascular accident
  • Myocardial infarction
  • Pulmonary embolism
  • Cardiac embolism

Payer coverage for sacroplasty may vary. Medtronic recommends providers review all payer coverage policies and/or call payers to determine coverage criteria and appropriate coding.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.

-end-

  1. Sudhir G., et al. Sacral Insufficiency Fractures Mimicking Lumbar Spine Pathology. Asian Spine J 2016;10(3):558-564
  2. Kortman K, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013 Sep 1;5(5):461-6.
  3. National Osteoporosis Foundation Website. www.nof.org
  4. Medtronic data on file. The mean radiation reduction at the hands was 77.79 percent (p<0.001). Based on an internal testing of 24 total cadaveric procedures (n=12 using Kyphon(TM) CDS and n=12 using Kyphon(TM) Bone Filler Device). Dosimeters were placed on the wrist and fingers to measure radiation when delivering bone cement into the vertebral body. Radiation result reported is based on adherence to the Directions for Use.

Contacts:
Victor Rocha
Public Relations
+1-901-399-2401

Ryan Weispfennig
Investor Relations
+1-763-505-4626

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