SPINAL & ORTHOPAEDIC ASC THERAPIES & PROCEDURES

WHAT WE OFFER

Our diverse portfolio of innovative, high-quality products and reliable therapies means that when a patient comes to your ASC, they will get the right product or therapy at the right time.1

Below are available products and services to assist you and your ASC designed for spinal & orthopaedic procedures.

Close-up Photo of Prestige Product

CERVICAL ARTHROPLASTY, PRESTIGE™ LP CERVICAL DISC

The Prestige LP™ cervical disc is the first FDA approved one- and two-level arthroplasty device to report 10-year IDE study data. The Prestige LP titanium ceramic composite material contains no nickel, cobalt, or chromium and allows for MRI clarity of the spine. The Prestige LP uses streamlined instrumentation designed for a smooth, repeatable workflow.2,3

VIEW 10 YEAR CLINICAL STUDY OUTCOMES

KEY FEATURES:

  • Two-piece articulating metal-on-metal device is designed to allow for motion after implantation
  • Proprietary titanium ceramic composite material contains no nickel, cobalt, or chromium
  • Titanium ceramic composite has a lower steady state wear rate of combined motion than stainless steel1
  • 10-year clinical study data for one-and two- level IDE trials
  • Consolidated instrument configuration for improved cost and efficiency*

Risks of the PRESTIGE LP™ Cervical Disc include, but are not limited to:

  • Foreign body reaction to the implant including possible rumor formation, autoimmune disease, metallosis, and/or scarring
  • Implant migration, implant subsidence and loss of fixation
  • Bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent level
  • Sizing issues with components
  • Development of new radiculopathy, myelopathy, or pain

* As compared to original Prestige LP Instruments (2014).

Indications, Safety, and Warnings

Close-up Image of ACDF Spine Essentials Product

ACDF, SPINE ESSENTIALS

The Spine Essentials™ Anterior Cervical Discectomy and Fusion (ACDF) offering combines portions of the Atlantis Essentials™ Anterior Cervical Plate System and Cornerstone® PSR Cervical Fusion System or allograft in an effort to deliver a system for 1-and 2-level ACDFs. The system consists of the following features:

KEY FEATURES:

  • Merges recognizable, market-leading fixation and interbody technologies already familiar to surgeons
  • Platform contains the most commonly used implant sizes for 1-and 2-level fusions
  • Includes all the tools needed to insert the implants
  • Implants are all sterile-packaged in just the right quantities
  • Instrument sets are significantly smaller
  • Saves space in the OR
  • Allows staff to be more efficient during 1-and 2-level procedures

Risks of Anterior Cervical Discectomy and Fusion surgery include, but are not limited to:

  • Tissue or nerve damage caused by improper positioning and place of implants or instruments
  • Fracture, micro fracture, resorption, damage or penetration of any spinal bone and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery

With Spine Essentials ACDF, we set out to make the most common cervical fusion procedures incredibly efficient without taking an eye off quality or outcomes.

Indications, Safety, and Warnings

LEARN MORE ABOUT SPINE ESSENTIALS
Close-up Photo Rialto Product

SI FUSION

Most SI fusion devices today are assisted by muscle/tissue retractors due to the transgluteal/lateral approach. Medtronic’s Rialto™ SI fusion procedure uses a posterior approach to the SI Joint, which has inherent benefits for surgeons and patients.**

EASIER ACCESS Implant passes through less tissue and muscle during implantation.
BETTER VISIBILITY Posterior access provides better visibility, especially when treating larger patients.
LESS INVASIVE Fewer muscles are disrupted using our posterior approach.
LESS SURGICAL STEPS Each Rialto™ device takes fewer surgical steps to implant under either navigation or fluoroscopy.

Risks of Rialto™ SI fusion include, but are not limited to:

  • Migration, loosening, or fracture of the implant
  • Metal sensitivity, or allergic reaction to a foreign body, debris, corrosion products including metallosis, staining, tumor formation and/or autoimmune disease
  • Decrease in bone density due to stress shielding

** Data was obtained through a survey of surgeons who had experience with both approaches.

Indications, Safety, and Warnings

LEARN MORE ABOUT RIALTO™ SI FUSION SYSTEM

ADDITIONAL PROCEDURAL SUPPORT

BIS™ monitoring system

RESPIRATORY MONITORING EQUIPMENT - BISPECTRAL INDEX (BIS™) MONITORING SYSTEM

Randomized controlled trials suggest compared to routine care, titrating anesthetic depth during TIVA using processed electroencephalography (pEEG) can reduce the amount of IV anesthesia used. The BIS™ monitoring system offers meaningful information you need to individualize and optimize anesthetic dosage — for the best possible outcome.

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McGRATH™ MAC video laryngoscope

MCGRATHTM MAC VIDEO LARYNGOSCOPE

The next generation McGRATH™ MAC video laryngoscope is an enhanced, more robust device, designed to be durable and used throughout the day. Add McGRATH™ to your ASC to make your first attempt your best.

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PATIENT OUTREACH TOOLS

PATIENT AMBASSADOR PROGRAMS:

PATIENT GUIDES & BROCHURES:

REIMBURSEMENT & CODING TOOLS

Medtronic SpineLine® brings day-to-day business and reimbursement systems into focus so that medical professionals are free to concentrate on clinical issues and patient care. Find out more about SpineLine — the best source for up-to-date research and clinical data to determine the benefits and outcomes of spine surgeries. 

Medical necessity will dictate site of service for each individual patient. Physicians should confirm inpatient or outpatient admission criteria before selecting site of service.

1

Medical necessity will dictate site of service for each individual patient. Physicians should confirm inpatient or outpatient admission criteria before selecting site of service.

2

Abkowitz, S, Abkowitz SM, Fisher H et. Al. The Development of Wear Resistant Titanium-Ceramic Composites for Orthopaedic Implant Devices. Proceedings from the Materials & Processes for Medical Devices Conference, August 25-27, 2004 St. Paul, Minnesota.

3

Based on mechanical testing according to ISO (18192-1) and ASTM (F2423-05).

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR THE PRESTIGE LP CERVICAL DISC:

The PRESTIGE LP Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays):  herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.  The PRESTIGE LP Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE LP Cervical Disc.

The PRESTIGE LP Cervical Disc should not be implanted in patients with active systemic infection or localized infection at the surgical site; osteoporosis or osteopenia defined as a DEXA bone mineral density T-score ≤ -1.0; allergy or sensitivity to titanium, aluminum or vanadium; marked cervical instability on neutral resting lateral or flexion/extension radiographs; translation >3.5mm and/or >11° rotational difference from that of either level adjacent to the treated levels; severe spondylosis at the level to be treated, characterized by bridging osteophytes, loss of disc height >50%, an absence of motion (<2°) as this may lead to a limited range of motion and may encourage bone formation (e.g. heterotopic ossification, fusion); severe facet joint arthropathy; significant cervical anatomical deformity or clinically compromised vertebral bodies at the affected level(s) due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis); or significant kyphotic deformity or significant reversal of lordosis.

The PRESTIGE LP Cervical Disc should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone adequate hands-on training in the use of this specific device. Only surgeons who are familiar with the implant components, instruments, procedure, clinical applications, biomechanics, adverse events, and risks associated with the PRESTIGE LP Cervical Disc should use this device. Medtronic will offer hands-on training to physicians prior to their first use of the device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, including neurological complications.

The safety and effectiveness of this device has not been established in patients with the following conditions: axial neck pain as the solitary symptom; skeletally immature patients, pediatric or adolescent children (<21 years old), or those over the age of 78; prior cervical spine surgery, including prior surgery at the index level or adjacent levels; more than two cervical discs or two non-adjacent cervical discs that require surgical treatment; facet joint pathology of involved vertebral bodies; spinal metastases; an endocrine or metabolic disease that affects bones such as Paget’s disease, osteomalacia, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta; chronic or acute renal failure or history of renal disease; taking medications known to potentially interfere with bone/soft tissue healing (e.g., steroids); diabetes mellitus requiring daily insulin management; serious mental illness; being treated for alcohol and/or drug abuse; and pregnant.

Devices with metal-on-metal articulating surfaces (such as the Prestige LP Cervical Disc) may release wear debris, metallic particles or metal ions locally near the device and/or systemically. The short and long term effects of the wear debris, metallic particles and metal ions on the body are not known, but certain groups of patients may be at a higher risk including patients who are pregnant, patients who are planning to get pregnant, and patients who have renal disease.

Patients in the clinical study of the PRESTIGE LP Cervical Disc were instructed to use non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks postoperatively. It has been reported in the literature that short-term postoperative use of NSAIDs may reduce the instance of heterotopic ossification (HO). To reduce the instance of HO, it is recommended that the PRESTIGE LP device be implanted in subjects able to tolerate the use of NSAIDs for two weeks post-operatively.  

Caution:  Federal law (USA) restricts this device to sale by or on the order of a physician.

Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.