Medical device industry outlook in 2017: 5 thoughts from AdvaMed President and CEO Scott Whitaker

Washington, D.C.-based AdvaMed President and CEO Scott Whitaker shared his thoughts on the device tax and device company inspections, as reported by Regulatory Affairs Professionals Society.

Aesculap offers warranty against delamination & visualization — A 1st in spine industry

Center Valley, Pa.-based Aesculap Implant Systems launched a warranty program for its Plasmapore surface-enhancing technology portfolio.

Here are five insights:

1. The surface-enhanced interbodies are designed for spinal fusion.

2. Under the warranty, Aesculap will give facilities a device replacement if a reoperation occurs due to a “clinically relevant delamination or the generation of impaction debris or a CT or MRI artifact caused by the device that impedes a physician’s ability to visualize adjacent anatomy.”

3. This warranty represents the first facility risk-share agreement on a titanium-enhanced PEEK interbody in the spine space, warranting against both delamination and visualization.

4. Surgeons have implanted more than 20,000 PlasmaporeXP devices, and more than 20 clinical studies exist on the devices.

5. Aesculap concurrently launched the TSpaceXP interbody system, which is coated with PlasmaporeXP surface enhancing technology.

“We created a program to demonstrate to healthcare providers that we believe in our product, our clinical data and our long-standing experience and ultimately share their goal of a lasting treatment for their patients’ chronic back issues,” said Chuck DiNardo, president, Aesculap Implant Systems.

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First Israeli hospital purchases EOS system — 4 things to know

Here are four things to know:

1. The platform will be installed at the Tel Aviv Sourasky Medical Center’s The Dana-Dwek Hospital in Tel Aviv later this month.

2. TAMC serves the 3.5 million people living in the Tel Aviv area, accounting for over 42 percent of Israel’s entire population.

3. EOS imaging CEO Marie Meynadier said, “Given [TAMC’s] status as a national reference site for orthopedic care, a large number of Israeli patients will now have access to our technology.”

4. The EOS platform has now been sold in 33 countries.

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Dr. Michael Fehlings to head 1st Canadian site for InVivo's cervical spinal cord injury study — 7 things to know

Toronto Western Hospital represents the first Canadian site for San Diego-based InVivo Therapeutics’ cervical spinal cord injury study.

Here are seven things to know:

1. Toronto Western Hospital’s Research Ethics Board approved patient enrollment in the study on March 30, 2017.

2. Michael Fehlings, MD, PhD, will serve as the site’s principal investigator for the cervical spinal cord injury study.

3. Dr. Fehlings serves as the director of the spinal program at Toronto Western Hospital’s Krembil Neuroscience Centre as well as a surgery professor and member of the Institute of Medical Sciences School of Graduate Studies.

4. He also serves as a scholar in the McLaughlin Centre of Molecular Medicine, a scientist in the McEwen Centre for Regenerative Medicine and a senior scientist at the Krembil Research Institute.

5. The director of the University of Toronto Neuroscience Program, Dr. Fehlings is also the co-director of the University of Toronto Spine Program and Krembil Chair in Neural Repair and Regeneration.

6. He has authored more than 725 peer-reviewed articles, many on the topic of SCI and complex spinal surgery.

7. Dr. Fehlings also serves as the site’s principal investigator for InVivo’s INSPIRE study.

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DePuy Synthes launches ATTUNE Revision Fixed Bearing Tibial Base and Cemented Stem — 5 notes

DePuy Synthes launched the ATTUNE Revision Fixed Bearing Tibial Base and the 14mm by 50 mm Cemented Stem.

Here are five things to know:

1. The ATTUNE Revision Fixed Bearing Tibial Base incorporates LOGICLOCK Tibial Base locking mechanism designed to enable enhanced kinematics, stability and wear reduction.

2. DePuy Synthes also launched the Cemented Stem to address more complex clinical needs and expand patients’ treatment options.

3. DePuy Synthes Global Knee Platform Leader Rajit Kamal said, “The ATTUNE Revision Fixed Bearing Tibial Base and Cemented Stem were developed to address more complex clinical needs and expand treatment options for patients. It will also extend DePuy Synthes leadership in the category of revision solutions.”

4. The revision system can be used with a cemented stem added intraoperatively in patients with clinical needs requiring supplement al fixation.

5. One-year results from worldwide studies revealed patients reported better outcome measures with the ATTUNE Knee than with other leading knee systems.

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ATTUNE Knee saves money and increases value — 5 takeaways

Here are five things to know:

1. The ATTUNE Knee advances patient outcomes and creates value for clinicians, providers and payers.

2. The ATTUNE Knee’s estimated cumulative percent revision was 1.39 percent at three years, translating to a 98.61 percent survivorship rate and comparing favorably to Cemented Total Knee Arthroplasty’s cumulative recent revision of 1.50 percent.

3. The device scored higher in marks pertaining to confidence in stability during activity, decreased knee pain, activities of daily living and quality of life.

4. Patients implanted with the ATTUNE Knee showed 39 percent lower odds of discharge to a nursing facility than those who received TKR with a Triathlon Knee.

5. Researchers pointed to a study revealing 35 percent of episodic costs come from post-hospital discharge care while a second study revealed the rate as 50 percent.

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Burst Biologics begins spinal fusion study — 5 takeaways

Boise, Idaho-based Burst Biologics will begin a study involving spinal fusion patients.

Here are five things to know:

1. The study will enroll 450 patients at 15 clinical sites throughout the U.S.

2. BioBurst Fluid, a cellular allograft found in umbilical cord blood, will be used in the study. The fluid has exhibited promising results in spinal fusion procedures.

3. Currently valued at $1.6 billion, the global spine biologics market is expected to reach $2.2 billion by 2022 and represents a significant opportunity for innovative biologic products.

4. Patients with poor health or low healing recovery would benefit most from successful studies investigating cellular content’s impact on spinal fusion.

5. Burst Biologics CEO Chris Jones said, “An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies… We want to demonstrate to spine surgeons and third-party payers that BioBurst Fluid can be successful in their more challenging patients.”

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