Stryker debuts a new 3D-printed Posterior Lumbar Cage

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Stryker’s Spine Division Debuts 3D-Printed Tritanium® Posterior Lumbar Cage at AANS Meeting (press release)

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will introduce the Tritanium Posterior Lumbar (PL) Cage, a 3D-printed intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease, at the American Association of Neurological Surgeons Annual Meeting April 30–May 4, 2016, in Chicago (booth No. 3611).

“Spine surgeons need a cage that has the capability of bony integration or bony in-growth, as well as radiolucency so that we can evaluate the fusion long term”

The Tritanium PL Cage is manufactured with Stryker’s innovative additive manufacturing process, also known as 3D printing. The cage is constructed using Stryker’s Spine division proprietary Tritanium technology, a novel, highly porous titanium alloy material designed for bone in-growth and biological fixation.1 Stryker’s 3D-printing process allows for the creation of porous structures that are designed to mimic cancellous bone, a type of spongy bone tissue.
“We are pleased to bring this technology advancement to spine surgeons and their patients,” said Stryker’s Spine division President Brad Paddock. “Stryker is a pioneer in 3D additive manufacturing, investing nearly 15 years in research and development. Unlike traditional manufacturing techniques, the flexibility of our 3D additive manufacturing capabilities allows us to precisely engineer and produce porous Tritanium devices. The Tritanium PL Cage is an exciting addition to our growing suite of unique spinal products.”
“Spine surgeons need a cage that has the capability of bony integration or bony in-growth, as well as radiolucency so that we can evaluate the fusion long term,” said Dr. Wellington Hsu, M.D., Orthopaedic Surgeon at Northwestern Medical Group. “Because Tritanium has favorable radiographic capabilities, as well as the integrative surface technology, that really in my opinion is what I would ask for from an interbody cage.”
Implanted via a posterior approach, the Tritanium PL Cage is available in a variety of widths, lengths, heights, and lordotic angles that can adapt to a variety of patient anatomies. Its large lateral windows and open architecture allow visualization of fusion on CT and X-ray, and its solid-tipped, precisely angled serrations are designed to allow for bidirectional fixation and to maximize surface area for endplate contact with the cage. The Tritanium PL Cage also is designed to minimize subsidence into the endplates.
The Tritanium PL Cage, which is produced at Stryker’s state-of-the-art 3D additive manufacturing facility, will be widely available to orthopaedic and neurosurgeons in mid-2016.
Tritanium Technology
In lumbar spinal fusion procedures, advancement of bony fusion at the target levels is at the cornerstone of a successful clinical outcome. In an effort to enhance the bony in-growth potential of implants, the scientific community has focused on porous metal implants in the hope of establishing a material similar in structure and mechanical properties to bone. Studies also have sought to understand which geometry and pore size would provide an optimal environment for cells to attach and multiply within this structure.2–4
Stryker’s Spine division conducted a pre-clinical animal study to investigate the biomechanical performance and bone in-growth potential of various lumbar interbody fusion implants utilizing different surface technologies (including the Tritanium PL Cage). The study has been accepted as a podium presentation at the NASS Annual Meeting being held Oct. 26-29, 2016, in Boston.
Indications for Use
The Tritanium PL Cage is indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease at one level or two contiguous levels from L2 to S1. Degenerative disc disease is back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The degenerative disc disease patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the Tritanium PL Cage may be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. It is to be implanted via a posterior approach and is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
Editor’s note: For images, video footage, or animation of Tritanium products and Stryker’s 3D additive manufacturing process, contact Barbara Sullivan at 714/374-6174 or [email protected]. A backgrounder about Tritanium and the Tritanium PL Cage also is available.
References

Project #43909: Tritanium Technology Claim Support.
Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. (1980) The optimum pore size for the fixation of porous-surfaced metal implants by the ingrowth of bone. Clinical Orthopaedics and Related Research, 150, 263-270.
Webster TJ, Ejiofor JU. (2004) Increased osteoblast adhesion on nanophase metals; Ti, Ti6AI4V, and CoCrMo. Biomaterials, 25, 4731-4739.
Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.

Content ID TRITA-PR-3

Contacts
Sullivan & Associates
Barbara Sullivan, 714/374-6174
[email protected]

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Real Career Advice for Young Engineers in Orthopedics

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I’m an Engineer with gray hair.  I worked in Product Development at six different orthopedics/spine companies over three decades. During this period, I have worked with hundreds of talented engineers.  I have witnessed poor career moves that have rendered Engineers stagnant for decades grinding it out in a cubical.   I also have seen brilliant career moves by Engineers who rocketed their careers within a few short years.
So, based on this experience, I would like to share advice for young Engineers who are ambitious and want rapid career progression.  This advice assumes that you have the right degree(s), you are competent and are working in an Orthopedics or Spine company.

Find a mentor – Many engineers who move up quickly in an organization have an informal “sponsor” in upper management who looks after them, shares their accomplishments in closed-door executive meetings and hooks them up for opportunities not available to the other faceless Engineers in the organization. Ask an executive inside or outside the company to be your mentor and have coffee with you once a month.  Believe me, he/she will be flattered and say “yes”.

Get closer to the customer – Bottom line. The Engineers who have more interaction with surgeons make more money and move up quicker.

Learn how to manage other engineers  –  It is not easy to go from being a single contributor (Engineer) to managing at least one person (Engineering Manager).  In order to jump the chasm, you must have some informal management experience. Find a way to get it. The Engineers who have “mentored” other Engineers on projects (even if you cannot say “managed” other Engineers on a project) are the ones who get the nod for the open Engineer Management position.

Learn how to delegate time-consuming detail work to others – Engineers who are on the fast-track get more work done each week than their peers.  Many fast-track engineers persuade others into helping them. “Please review this design, review this test plan, go to this meeting for me, talk to this vendor while you are there, add my quote to yours, etc.”  By delegating some of the time-consuming detail work, fast-track Engineers have more time to work on the other areas for advancement.

Hon your Communication Skills – Management loves the Engineers who can articulate complex projects to others.  Engineers who can express themselves clearly get invited to present to management, investors, regulatory agencies, surgeons, etc.  Be one of those Engineers.  Take a course. Read books on effective oral communication. Watch and learn from other great presenters.

Build a project portfolio –  Each time you complete a large or challenging project add it to your LinkedIn profile. LinkedIN Portfolio allows you to create a wall of projects by adding text, images, outside links, and videos.  Use it.

Ask questions in group meetings – Perhaps the best way to gain visibility in a company is to ask questions in public settings. You don’t have to be the smartest person in the room to ask a question. Most likely all of your fellow Engineers have the same question anyway. Be the one who asks for it.

Assume responsibility for things that need fixing –  Don’t ask for permission.  Take responsibility for designs, procedures, processes, presentations, reports that are broken and fix one, even if it is not in your job description. Management loves this and will label you a “go-getter”.

Find a way to get into surgery –  Every company is different.  As crazy as it seems, many Ortho/Spine companies don’t want “rookie” engineers to attend surgeries.  Tell your boss you want to go.  Heck, tell everyone. Invite yourself. Tell every sales person that you meet that you want to attend (the secret:  many sales pros “love” to have Engineers in the OR because it makes him/her look better in front of the surgeon.)

Invite a company executive to breakfast or lunch –  Tell your supervisor so he/she doesn’t get blind-sided.  You will be surprised when the executive says “sure”.  Have a bunch of questions prepared (the secret: it’s really a chance for you to get visibility with upper management).  Engineers who are “known” by upper management tend to get promoted faster.

Present your own work – Don’t let your supervisor present your design and testing work. Insist on presenting your work directly to management.   To make your boss more comfortable, do a practice presentation to your boss so he/she can see that you will not make a fool of him/her.

Spend less time on CAD – This may be counterintuitive, but the more time you are on CAD the less time you have for the other 15 areas. Great CAD work will not get you promoted.

Don’t worry about your salary – Early in your career, experience trumps salary.  After 10 years, you can start to compare titles and salaries with others, but for now get the most experience as fast as possible.

Network within your field – Yes. Network like crazy with people at other companies, and don’t burn bridges. This industry is small. Your next job will likely come from someone in your network.

Don’t get an MBA –  But instead, learn what you need to learn about the business aspects from people who have complementary skills.  Learn basic accounting, ROI, earnings, SG&A, differences in start-up company legal structures (LLC, C-Corp…), and project/time management.   An advanced engineering degree (masters or Ph.D.), focused certification course (FDA/ISO seminars, Executive training course, patent agent license training…) are better for career advancement than an MBA.

Go work for a startup – Yes, at least once in your career. There are many advantages to working in a startup – here are 7 of them.

Thoughts?
[email protected]

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Stryker acquires Stanmore Implants for $52M

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Stryker (SYK) Acquires Stanmore Implants in GBP 35.6M Deal (StreetInsider)
Stryker (NYSE: SYK) announced it has acquired Stanmore Implants Worldwide Limited from SIW Holdings Limited in an all cash transaction for £35.6 million. Stanmore Implants is an innovative orthopaedic business focused on serving the needs of surgeons that treat adult and juvenile orthopaedic oncology. Stanmore Implants’ portfolio includes both patient specific and off-the-shelf implant systems aimed at limb salvage.
“The acquisition of Stanmore Implants provides Stryker with differentiated technologies designed to provide the most effective solutions for orthopaedic oncology surgeons. This addition underscores Stryker’s commitment to our core joint replacement business and expands our presence in the global orthopaedic oncology market,” said David Floyd, Group President, Stryker Orthopaedics.
“The combination of Stryker’s commitment to orthopaedic oncology and Stanmore’s novel orthopaedic oncology solutions provides a unique opportunity to impact a broader group of patients globally,” said Michael Mainelli, Chief Executive Officer, Stanmore Implants.

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Verticore offers a crowfunded solution for low back pain without surgery

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VERTECORE: CROWDFUNDING FOR MOBILE SPINAL DECOMPRESSION (Orthopedics This Week)
website… Vertecore Lift
Go ask “the people”…VerteCore Technologies is doing just that with the launch of its crowdfunding campaign for the financing of the first production run of its brand new VerteCore Lift. The company says that it has worked with leading mechanical and electrical engineers on several different prototypes. As indicated in the April 11, 2016 news release, “The VerteCore Lift provides affordable, comfortable, convenient, mobile spinal decompression for people who suffer from chronic lower back pain created by bulging discs, herniated discs and other spine conditions that put pressure on and pinch sensitive spinal cord nerves.”

“The VerteCore Lift has been evaluated and peer-reviewed by a wide range of medical doctors that see the FDA Class 1-cleared medical device as a tremendous step forward in providing a more effective solution at treating many different forms of low back pain including degenerative disc disease, sacroiliac joint dysfunction, sciatica, spinal lumbar stenosis, functional scoliosis, bulging and herniated discs.”
As the name implies, the Lift effectively stretches or decompresses the spine and allows the ruptured annulus fibrosus of intervertebral discs to go through a process known as “resorption,” which means when pressure is relieved, it allows the ruptured disc’s nucleus pulposus to retreat back inside the annulus fibrosus thus decreasing pressure on spinal nerve roots which cause low back pain.
Paul Leake, CEO, VerteCore Technologies, told OTW, “Early on, as a patient looking to avoid surgery, the challenge was finding reliable information about alternative back pain treatments. Between my co-inventor and I, we had tried just about every product we could get our hands on. From those purchased through clinicians to ones that are advertised on late night infomercials. Either they did nothing or just did not perform as advertised. It was very frustrating trying to find an effective alternative to surgery. Especially when you factor in the desire for convenience and wanting a more active lifestyle as opposed to your life revolving around time consuming doctor appointments and taking pain meds.”
“Once an effective prototype of the VerteCore Lift was developed, the challenges shifted over to those more typical for medical device innovations: testing, securing IP, FDA clearance, and now we’re moving onto validation as we educate the general public with back pain and the clinicians that treat these patients symptoms.”
“I would never presume to tell a doctor what protocols to follow, but in relaying the universal need of patients to know the alternatives available, I would ask that they embrace a patient-centric approach.”
“The VerteCore Lift was designed to provide a convenient, non-intrusive, viable option to explore before surgery and the potential risk from opioid complications while trying to mitigate pain. The Lift has been extremely effective and the convenience to the patients means they are more likely to adhere to the doctor’s treatment plan. Being able to decompress the spine during normal daytime activities is the main product feature that sets the VerteCore Lift apart from other traction medical devices. It is the perfect “last step” for patients who are considering back surgery.”

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Startup solves the irreparable rotator cuff problem with balloon technology

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Balloon for Irreparable Rotator Cuffs! (Orthopedics This Week)
see also…   50 Companies that are leading innovation in Sports Medicine
Balloon as spacer/re-educator…Joseph A. Abboud, M.D., an orthopedic surgeon at the Rothman Institute in Philadelphia, is helping patients who have suffered massive irreparable rotator cuff (RC) tears. Dr. Abboud tells OTW, “There are many patients with these types of tears who have been told that they cannot be helped arthroscopically. An FDA IDE [investigational device exemption] study is now underway in the U.S. at several centers, including The Rothman Institute in Philadelphia, Pennsylvania, to evaluate a new device called InSpace. This device, is manufactured by an Israeli company named OrthoSpace and has been approved and available in Europe for over five years with encouraging data reported.”
“With difficult RC tears you may not be able to bring the tissue of the rotator cuff back to the bone effectively thus impacting the healing cascade. One way to circumvent this problem is to use reverse shoulder arthroplasty (RSA); which is a fairly invasive procedure. The InSpace technology, which works in the subacromial space, involves inserting a saline-filled biodegradable balloon that is inflated to the precise amount needed for the shoulder in question. The procedure, unlike RSA, is done arthroscopically in 10-15 minutes.”
“The balloon sits between the humeral head and the acromion and helps to re-center the humeral head relative to the glenoid. The thought is that by helping to re-center the humeral head, you are redirecting some of the muscle forces across the joint. Therefore the net vector of forces around the joint are closer to what we have in the native normal joint than the decompensated chronic rotator cuff deficient shoulder. We also know that patients who have chronic progressive rotator cuff tears often develop the ability to compensate for their deficient rotator cuff without even being aware of this learned behavior. By inserting this biodegradable balloon we are providing the shoulder the opportunity to potentially learn this compensatory behavior in the hopes that the patient develops a chronic compensated and asymptomatic rotator cuff tear type shoulder. In essence we are not fixing the irreparable rotator cuff, rather we are re-educating the shoulder so that it learns to compensate better. Within three months the biodegradable material loses its ‘balloon’ state and is fully resorbed by twelve months.”
“The potential benefits of this type of procedure are substantial, including the ability to have it done arthroscopically with a short anesthesia time, reduction in pain and a potential for increase in function. And theoretically, depending on the study outcome, there is the potential in the future that if over time symptoms recur, we could repeat the procedure with few downsides. As with any FDA IDE study, we have to see what the final data analysis shows to be sure this will be an efficacious intervention for our patients in the future.”

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