Verb’s Huennekens unveils vision of next-gen robotic surgery

by Stacy Lawrence

Verb Surgical is working on what it sees as “Surgery 4.0”: the next iteration of surgery that incorporates robotics, advanced visualization, machine learning, data analytics and connectivity. It expects that its technology could translate into real access for billions globally who currently don’t have access to surgery by lowering costs and reducing the training threshold.

Along with Johnson & Johnson’s ($JNJ) Ethicon and Alphabet’s ($GOOG) Verily, Verb expects to have a fully working prototype surgical system by year end. Ethicon already divulged earlier this year that there was a prototype of the robotic system. A surgical system isn’t expected to be on the market, though, until 2020.

“We envision a future in surgery where we move from having a mainframe computer to a PC on every desk to a cell phone in every pocket,” Verb President and CEO Scott Huennekens toldFierceMedicalDevices. “Everybody has access at a much lower cost with a much lower threshold for training.”

He said that Ethicon is specifically contributing its surgical instrumentation, while Verily and Google are bringing to the table data analytics and machine learning tech. The expectation is that these surgical systems will talk to each other–and learn systematically.



TraumaCad Sales Cement Brainlab Position as UK Market Leader for Orthopedic Surgical Planning

 September 28, 2016

LONDON–(BUSINESS WIRE)–Brainlab, a global leader in medical technology, announced today that it has solidified its position as the dominant force in orthopedic surgical planning, adding 20 new TraumaCad® sites in the United Kingdom in the past 12 months. With consistent annual sales growth in the U.K. of approximately 10 percent, TraumaCad is now available in nearly 70 percent of hospitals in the U.K.

“Before we started using TraumaCad, in January 2016, my colleagues and I were well aware of its excellent reputation amongst our colleagues elsewhere,” said Simon Royston, Sheffield Teaching Hospitals, NHS Trust. “We have found it very intuitive to use and it has been a step-up in the ease and quality of our pre-operative planning. The training and technical support from Brainlab has been superb, all the way from pre-installation to the present.”

Installed at over 2,000 locations worldwide, TraumaCad surgical planning by Brainlab, provides orthopedic surgeons with a comprehensive digital solution for performing pre-operative planning and simulations. The procedure-oriented application includes an extensive digital template library and offers a full set of wizards and measurement tools. Using digital images, surgeons can perform measurements, assess prostheses, simulate osteotomies, and visualize fracture reductions.

“Our explosive growth in TraumaCad sales is not only a great validation of the quality and reputation of our technology, but it is also an important recognition of the growing demand for hospitals and clinics to stay ahead of the curve in orthopedic treatments,” said Ian Wilson, Sales Manager, on behalf of Brainlab. “In most cases, the UK hospitals and clinics that have purchased TraumaCad in the past year or two have replaced other digital templating solutions.”

For more information on TraumaCad, visit

About Brainlab

Brainlab, headquartered in Munich develops, manufactures and markets software-driven medical technology, enabling access to advanced, less invasive patient treatments.

Core products center on information-guided surgery, radiosurgery, precision radiation therapy, digital operating room integration, and information and knowledge exchange. Brainlab technology powers treatments in radiosurgery and radiotherapy as well as numerous surgical fields including neurosurgery, orthopedic, ENT, CMF, spine and trauma.

Privately held since its formation in Munich, Germany in 1989, Brainlab has more than 11,000 systems installed in about 100 countries. Brainlab employs 1,350 people in 19 offices worldwide, including 385 Research & Development engineers, who form a crucial part of the product development team.


Anna Bliss
T: +49 89 99 156 8172

Northwestern Scientists Create Synthetic Bone Using 3-D Printer

Kristen Thometz | September 28, 2016

New technology developed in Chicago could lead to major advances in healing broken bones and other sports medicine injuries.

Using a commercially available 3-D printer and custom ink formulation, Northwestern University researchers created a synthetic bone capable of stimulating new bone growth.

“Ideally, it would be great if we could have these printers in a hospital setting where we can provide them the hyper-elastic bone ink, and then they can make patient-specific implants that day,” said Ramille Shah, assistant professor in the department of materials science and engineering, and surgery transplant division at Northwestern University.

“I think that is a possibility with this material.”

When used in recent studies, these 3-D printed bones successfully repaired spinal injuries in rodents and a large skull defect in a monkey. Those findings are being published Wednesday in the peer-reviewed journal Science Translational Medicine.

Printing a better bone

Shah heads a research lab at Northwestern that has spent the last several years working on developing 3-D printable materials, including the development of 3-D inks for both biomedical and non-biomedical applications.

Through this work researchers developed a “unique 3-D ink formulation” that makes it possible to print 3-D objects primarily composed of the main mineral found in natural bone tissue, Shah said. The other component of the 3-D ink is both biocompatible and biodegradable.

The printed product, which researchers are calling hyper-elastic bone, is “highly elastic,” even though it’s primarily made up of material that tends to be “very brittle,” Shah said.



Blue Cross Blue Shield of Nebraska Adopts Positive Coverage for Minimally Invasive Sacroiliac Joint Fusion

SAN JOSE, Calif., Sept. 28, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield (BCBS) of Nebraska has updated its medical policy to provide coverage for minimally invasive SI joint fusion using CPT 27279.  BCBS of Nebraska becomes the second BCBS plan following Michigan to establish a positive coverage policy for MIS SI joint fusion.  The new policy is based on a review of published clinical literature available as of March, 2016 and states: “fusion/stabilization of the sacroiliac joint for the treatment of back pain is scientifically validated when the patient has had a positive result with dual diagnostic blocks using 2 anesthetic agents with different duration of action and has tried and failed therapeutic injections and has tried and failed 12 weeks of conservative management which must consist of documented physical therapy and nonsteroidal anti-inflammatory medications.”

References cited within the new coverage policy consisted of published studies specific to iFuse1,2.  iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed positive publications.  No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication citing clinical studies that demonstrate improved pain, patient function and quality of life.

“BCBS of Nebraska joins BCBS of Michigan along with a growing list of leading edge private insurers as well as Medicare nationwide to provide coverage for iFuse.  This positive coverage decision provides access to appropriate care for Blue Cross Blue Shield members throughout Nebraska who have been suffering with chronic SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption,” said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.

“I see patients in my practice on a regular basis who have suffered from chronic sacroiliac joint dysfunction for years and no longer respond to non-surgical treatment.  Many of these patients are surgical candidates,” said John Hain, MD at Nebraska Spine Hospital in Omaha, Nebraska.  “I am pleased that I can now offer my BCBS Nebraska patients the only minimally invasive procedure supported by two year outcomes data and give them a chance to have a better quality of life.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company develops, manufactures and markets minimally invasive products for the SI joint.  SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion.  iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (  It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit:

Get a new body part and go home the same day: the rise of the ‘bedless hospital’


BRECKSVILLE, Ohio — Get in, get a new knee, go home.

As treatments get less invasive and recovery times shrink, a new kind of hospital is cropping up — the “bedless hospital.”

They have all the capabilities of traditional hospitals: operating rooms, infusion suites, and even emergency rooms and helipads. What they don’t have is overnight space.

“It reduces cost, and it reduces the risk of infection,” said Dr. Akram Boutros, CEO of MetroHealth System, which just opened a $48 million bedless hospital near Cleveland that he expects will serve about 3,000 people in the first year. “People go home to a less-risky environment, where they tend to get better faster.”

The growth in outpatient healthcare is a fundamental shift in US medicine. MetroHealth, which gets part of its funding from taxpayers and serves a large Medicaid population, has expanded outpatient visits from 850,000 to 1.2 million in the last four years, a 40 percent increase.

Outpatient visits, experts say, subsidize more expensive inpatient treatment.

But some observers worry that the development of bedless hospitals is part of a financial shell game hospitals must play to make the dollars match up with the care they offer. And they wonder if such facilities are diverting resources away from a large population of patients who still require more complex treatment.

“The untold story is what’s happening to all of those patients who do still need to be in the hospital,” said Harold Miller, chief executive of the Center for Health Care Quality and Payment Reform. “And are the places where they are going getting paid enough to support good care?”


Intuitive Surgical at 52-Week High on High Procedural Volume

Zacks – September 28, 2016

Share price of Intuitive Surgical Inc. ISRG rallied to a 52-week high of $720.94 on Sep 27, eventually closing a tad lower at $720.19. This represents a strong year-to-date return of about 31.86%, much better than the S&P 500’s return of 5.67% over the same time frame.

Currently, Intuitive Surgical carries a Zacks Rank #3 (Hold). The stock has a market cap of 27.22 billion and a long-term expected earnings growth rate of 11.26%.

Key Catalysts

We believe that growing adoption of Intuitive Surgical’s da Vinci system among physicians for general surgery, oncology, urology and gynecology procedures is a key growth catalyst. Moreover, increasing procedural volume outside the U.S. presents a significant growth opportunity for the company. Further, the integrated Table Motion product line has gained traction within a short span of time. This will likely boost top-line growth.

Meanwhile, increased spending on product development and higher investment in expanding the company’s footprint in international markets (particularly in Europe) are prudent moves to drive long-term growth.

Intuitive Surgical had impressed in the second quarter of 2016 with exceptional global procedure growth, solid capital placement, strong product margin and new product launches. Notably, the company reported adjusted earnings of $4.86 per share, which beat the Zacks Consensus Estimate by 65 cents.

Titan Medical Provides Corporate Update

TORONTO, ON–(Marketwired – September 27, 2016) – Titan Medical Inc. (TMD.TO) (TITXF), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (MIS), today provided an update of corporate activities and operational progress.

On September 20 2016, Titan completed a public offering of units which raised approximately US $7.2 million from US and Canadian investors. As a result of the transaction, management currently anticipates closing the third quarter ending September 30, 2016 with approximately US $8.5 million in cash.

“As a result of the recent fund raising, we have initiated active discussions with our principal development partners to implement key components of the SPORT Surgical System’s development plans within our current financial resources,” said John Hargrove, Chief Executive Officer. “At this point, we believe the resources we have on hand enable us to move forward with the advancement of human factors and usability studies of the surgical system.”

As part of the succession plan for senior management, Titan has engaged an executive search firm for the purpose of assisting in the identification and qualification of a Chief Operating Officer, whose responsibilities will include capital markets involvement, and a Vice President of Engineering to assist in product development and project management.

In addition to the operational activities, that management is focused on, the Board continues its active search to recruit a new Chairperson. We are also continuing an ongoing program of board renewal. As we achieve operational and development milestones, as well as the progress regarding our Chairperson search, we will promptly inform our shareholders.

About Titan Medical Inc.

Titan Medical Inc. is a Canadian public company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (“MIS”). The Company’s SPORT™ Surgical System, currently under development, includes a surgeon-controlled robotic platform that incorporates a 3D high-definition vision system and multi-articulating instruments for performing MIS procedures through a single incision. The surgical system also includes a surgeon workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view of inside a patient’s body. The SPORT™ Surgical System is designed to enable surgeons to perform a broad set of surgical procedures for general abdominal, gynecologic, and urologic indications. For more information, visit the Company’s website at

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 30, 2016 (which may be viewed at Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

CT Surgeon gives patients pain relief with an innovative procedure to treat stress fractures

(DANBURY, CT) – September 9, 2016 – When his knee quickly swelled to three times its normal size after falling on the stairs, Nicholas Saccone of Carmel, NY knew something was seriously wrong. Saccone, 69, wasn’t able to walk or bend his knee and pain radiated throughout his leg. He immediately contacted Dr. Daniel Fish, a surgeon with Orthopaedic Specialists of Connecticut who had performed previous meniscus surgery on him.
An MRI and X-ray revealed that Saccone had arthritis and had also developed a stress fracture of the knee, but instead of a full knee replacement, Dr. Fish suggested a relatively new procedure called Subchondroplasty. Dr. Fish and two other doctors with Western Connecticut Health Network (WCHN) are among only a handful of surgeons in Connecticut trained to use this revolutionary technique.
“This procedure is ideal for patients with knee pain and decreased joint function caused by small cracks or stress fractures,” explained Dr. Fish. “We inject a calcium phosphate compound that seals the crack, similar to caulking.”
Specifically, surgeons use an injectable, bone graft substitute material called AccuFill® that is intended to fill voids or gaps in the skeletal system. It flows readily to fill bone defects, then crystallizes and sets to form a scaffold in the bone. The compound promotes new bone growth and is naturally replaced with the new bone during the healing process. The FDA approved the material in 2010.
According to the Centers for Disease Control and Prevention (CDC), 719,000 Americans had a full knee replacement in 2010. That same year, the National Center for Health Statistics released a report that shows hospitalization rates for knee replacements more than doubled over a ten year period for adults aged 55-64.
Dr. Fish and his partner Dr. Robert Daher, and colleague Dr. Matthew Rogell, have offered the procedure for the past two years.

“Before Subchondroplasty, there were limited treatment options for this type of injury,” said Dr. Rogell. “Often the only treatment option for patients in significant pain was a more invasive knee replacement.”
For Saccone, his operation was performed at 7:00 a.m. and by noon he was back in his home and able to move around.
“On just the fourth day after my surgery, I was walking without a cane. I couldn’t believe it.” Saccone said. Eight months later, Saccone remains very active, walking 1 ½ miles per day. He just returned from a trip to Atlantic City where he easily walked up and down the boardwalk.
The minimally invasive surgery is a 30-minute outpatient procedure performed under regional anesthesia, so the patient remains awake. The knee can be quite uncomfortable for 24-48 hours after the procedure, but then the pain resolves rapidly. Patients are on crutches for three to five days postoperatively. Most see a complete recovery in four to six weeks.

“Studies have indicated that the benefits can last for more than five years,” Dr. Fish said. “Additionally, this procedure will not limit treatment options for a partial or full joint replacement further down the road if needed.”
Dr. Fish is an examiner for the American Board of Orthopedic Surgery as well as an editorial reviewer for The Journal of Bone & Joint Surgery and the American Journal of Sports Medicine.

“Reviewing the latest research for publication in national orthopedic journals,” he said, “allows me to stay current while evaluating the risks and benefits of new technologies.” Dr. Fish has not yet performed the Subchondroplasty procedure on other weight-bearing joints such as the hip or ankle but he said the potential exists.
Dr. Fish and Dr. Daher are partners at Orthopedic Specialists of Connecticut, based in Brookfield, CT. They both reside in Ridgefield, CT. Learn more by visiting Dr. Rogell is a partner with Connecticut Family Orthopedics based in Danbury. He resides in Redding, CT. For more information about Dr. Rogell, contact

Western Connecticut Health Network (WCHN) is the region’s premier, patient-centred health care organization built for the people we serve in Western Connecticut and adjacent New York. WCHN is anchored by three nationally recognized hospitals, Danbury Hospital, New Milford Hospital and Norwalk Hospital, with the continuum of outpatient health and wellness services offered by numerous medical practices and sub-specialties across the region through the Western Connecticut Medical Group, the Western Connecticut Home Care. Committed to learning and innovation, our hospitals collaborate with the University of Vermont Medical College and many other well-known academic institutions to promote the most progressive care possible. The nationally renowned WCHN Research Institute, the WCHN Foundation and Norwalk Hospital Foundation and other affiliates complete the WCHN family where We Know You Well! For more information, visit Share your comments with us at; and/or


(DANBURY, CT ) – September 9, 2016 – Every year, 31 million Americans grumble “Oh my aching back”. Low back pain can range from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. Pinpointing the source of the pain and proper treatment is complicated enough, but what if the pain isn’t really caused by a problem with the spine?
Dr. David A. Bomback, a Spine and Scoliosis Surgeon with Connecticut Neck and Back Specialists, LLC in Danbury and performs surgery at Danbury Hospital, is helping patients find relief by treating a little known condition called sacroiliac joint dysfunction. Dr. Bomback is the first surgeon at Danbury Hospital to treat the condition with a sacroiliac joint fusion procedure and one of only a few surgeons in the entire state.

Where is the sacroiliac joint?
The sacroiliac joint connects the sacrum, the lowest bony segment of the spine, with the pelvis. The sacroiliac joint transmits most of the load from the upper body to the lower limbs, acting as a shock absorber in relieving forces on the spine. The joint is reinforced and supported by very strong ligaments. Occasionally, these ligaments can become too loose or too stiff so that the joint itself becomes arthritic, leading to persistent pain.
What causes sacroiliac joint dysfunction?
Sacroiliac issues are most commonly seen in mothers who have ligament loosening due to pregnancy, patients who have suffered trauma from an injury or accident, patients with certain arthritic conditions, and patients with previous lower back surgery (especially previous lumbar fusions). Approximately 25% of patients who visit spine surgeons actually have sacroiliac pain as that cause of his or her back pain rather than true lumbar (lower back pain).


Tough to Diagnose
Unfortunately, most tests including MRIs, x-rays, and CAT scans do not detect sacroiliac joint dysfunction, making the diagnosis challenging. “The diagnosis is truly made by sitting down and talking to the patient and getting an appropriate history, as well as a physical exam consistent with sacroiliac joint dysfunction,” explains Dr. Bomback. “When I examine a patient with sacroiliac pain, I stress the sacroiliac joint in a number of ways to see if I can elicit and/or reproduce the patient’s pain.”
Common Causes of Back Pain
The vast majority of low back pain is mechanical in nature, meaning damage to a vertebra of the lower spine. In many cases, it is caused by general degeneration of the spine associated with normal wear and tear that occurs in the joints, discs, and bones of the spine as people get older. Sprains, strains and traumatic injury are also contributors.
According to the National Institute of Neurological Disorders and Stroke, about 80% of adults experience low back pain at some point in their lifetimes. It is the most common cause of job-related disability and a leading contributor to missed work days. About 20% of back pain sufferers develop chronic pain with persistent symptoms lasting over one year. In some cases, treatment successfully relieves chronic pain, but in other cases pain persists despite medical and surgical treatment.
“Spinal surgeries at times can have a poor outcome if the diagnosis is made prematurely or incorrectly,” notes Dr. Bomback. “It is critical that the diagnosis of sacroiliac dysfunction is made appropriately, often times after diagnostic injections.”

The nuts and bolts of sacroiliac joint fusion surgery

The surgery involves a minimally invasive approach, placing three screws across the sacroiliac joint, bridging the spine to the pelvis to eliminate any abnormal motion thus allowing the joint to fuse over time. The surgery significantly reduces and oftentimes completely relieves the pain. An incision less than 1 inch in size is made through a tiny tube guided by a live x-ray. The surgery takes approximately 30 minutes and there is minimal and often no blood loss. The patient can usually go home the same day or occasionally after a one night hospital stay.

“The procedure has been around for approximately five to seven years,” said Dr. Bomback. “To date, approximately 19,000 patients have had the surgery in this country. We feel it is likely a permanent solution to the cause of their lower back pain and therefore offers an improvement in their quality of life.”

For more information on sacroiliac joint fusion surgery or to learn if you are a candidate for the procedure, please call 203-744-9700 or visit

About Western Connecticut Health Network
Western Connecticut Health Network (WCHN) is the region’s premier, patient-centred health care organization built for the people we serve in Western Connecticut and adjacent New York. WCHN is anchored by three nationally recognized hospitals, Danbury Hospital, New Milford Hospital and Norwalk, with the continuum of outpatient health and wellness services offered by numerous medical practices and sub-specialties across the region through the Western Connecticut Medical Group, the Western Connecticut Home Care. Committed to learning and innovation, our hospitals collaborate with the University of Vermont Medical College and many other well-known academic institutions to promote the most progressive care possible. The nationally renowned WCHN Research Institute, the WCHN Foundation and Norwalk Hospital Foundation and other affiliates complete the WCHN family where We Know You Well! For more information, visit Share your comments with us at; and/

Mainstay Medical ReActiv8-A sustains performance at one year in clinical trial

27th September 2016

Mainstay Medical has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling chronic low back pain and few other treatment options.

The one-year results show sustained performance in the ReActiv8-A Clinical Trial at the one-year follow-up with a clinically important, statistically significant and lasting improvement in the study’s key endpoints for pain (NRS), disability (ODI) and quality of life (EQ-5D).

Peter Crosby, chief executive officer of Mainstay, says, “We are very encouraged to see such strong and lasting benefits in this difficult-to-treat population. After one year of ReActiv8 treatment, 88% of subjects reported a clinically important improvement in one or more of the study endpoints, 81% were satisfied or very satisfied with the treatment and the majority continued to use the ReActiv8 treatment.”

The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have completed the 90-day follow-up, 45 the 180-day follow-up and 41 the one-year follow-up.

To facilitate future comparison of results in the ReActiv8-A and the ReActiv8-B trial, all outcomes are presented relative to the data collected at the enrolment visit, according to a company release.

Results for all subjects at 90 days, 180 days and 1 year respectively are:

  • Ninety-three per cent, 87% and 88% with clinically important improvement in one or more of the study’s key endpoints.
  • Sixty-three per cent, 58% and 56% with clinically important improvement in low back pain NRS on the day.
  • Fifty per cent, 53% and 59% with clinically important improvement in ODI.
  • Eighty-nine per cent, 82% and 80% with clinically important improvement in EQ-5D.
  • Sixty-one per cent, 67% and 62% reported>50% pain relief.
  • Eighty-nine per cent, 84% and 81% were satisfied with ReActiv8 treatment.

The results for EQ-5D and ODI previously announced were relative to data collected at the pre-implant visit to 90 days and 180 days and were:

  • Fifty-sevent per cent and 60% with clinically important improvement in ODI.
  • Sixty-seven per cent and 73% with clinically important improvement in EQ-5D.

Adverse events incidence and type were comparable to those in clinical trials reported for other neurostimulation devices, according to the release, with no unanticipated adverse events, and no serious adverse events related to the device, therapy or procedure.