About | Tiger Buford

Analyst: Uptake for robotic knee procedures will depend more on marketing than evidence

Analyst: Uptake for robotic knee procedures will depend more on marketing than evidence (MassDevice)
The adoption of robot-assisted total knee replacements will depend more on marketing that data or outcomes, Leerink Partners analysts wrote yesterday, as the leading contenders prepare to unveil their robotic total knee systems at an upcoming orthopedics conference.
Based on a conference call with a pair of orthopedic surgeons who each perform roughly 200 knee cases annually, the Leerink analysts said their experts believe the gain from robotic technologies will be incremental at best.
“While robotics could improve technique for ‘lower quality’ surgeons, both specialists expressed doubt as to whether the evidence would ever bear out in favor of robotics. Rather, in their minds, it is the ability to attract new patients to the hospital that will make or break robotic adoption,” analysts Richard Newitter and Ravi Misra wrote in a March 2 note to investors. “In their view the appeal of robotics to patients is more around the concept than brand (i.e., robotics vs. MAKOplasty or BlueBelt or “Omniplasty”) and thus [the] specialists believe that ultimately they will be able to pull in patients by advertising ‘robotics’ vs. a particular robotic platform.”
That said, the analysts wrote, the marketing edge belongs to centers in more-affluent cities where patients will seek out providers that offer robotics. More rural settings offer little or no choice of provider or are far from places that might offer robotics, according to the note. But the doc-shopping patients in the more affluent areas could swing 15% to 20% of the market to robotics, Newitter and Misra wrote.
Stryker (NYSE:SYK), which was the 1st major ortho player to get into robotics with the $1.7 billion purchase of Mako Surgical in December 2013, is still the leader of the pack, with Smith & Nephew (NYSE:SNN) and its $275 million Blue Belt acquisition following close behind. Both companies are expected to debut their total knee solutions at the annual meeting of the American Academy of Orthopedic Surgeons in San Diego this month.
The analysts said their experts say Stryker and Smith & Nephew are likely to take market share “at the expense of ‘have-nots’” such as Zimmer Biomet (NYSE:ZBH) and Johnson & Johnson (NYSE:JNJ), but the “adoption curve may be more gradual than hockey-stick-like.”
“Both specialists agreed that if ZBH or JNJ were to launch a robotics platform or acquire one of the private ones, they likely would be able to fend off mkt share loss and participate in any shift to robotics that is set to occur in the marketplace,” the analysts wrote.
“SYK/MAKO [is] clearly the iconic robot brand today, but barriers-to-entry may be lower than appreciated; other systems and competitive response from non-robotics players bear watching,” Newitter and Misra wrote. “Specialists agreed that right now SYK/MAKO is the platform to beat (followed by SNN/BlueBelt) given a strong first mover advantage and fact that an experienced player such as Stryker ‘struck first’ and is now behind the initial robotics push into total knees.”
However, that edge will dissipate over time, they wrote, and Zimmer Biomet and J&J could gain on the flip side of the coin: Hips.

The Medial-Pivot knee system is a winner in long term clinical results

MicroPort Orthopedics touts high satisfaction, survivorship in Medial-Pivot knee system study (Mass Device)
MicroPort Orthopedics today released the results from a study of its Medial-Pivot knee system, touting high rates of satisfaction and survivorship at 17 years.
Results from the trial, including long-term clinical and radiographic outcomes, were published in the medical journal The Knee.
Data from the 325 patient trial exploring patients with knee osteoarthritis who underwent total knee arthroplasty procedures using the company’s Medial-Pivot prosthesis indicated a statistically significant improvement on the Knee Society clinical rating system.
Improvements were also noted on the Western Ontario and McMaster Universities Osteoarthritis index, as well as the Oxford knee score, the company said. A total of 94% of patients were able to perform age-appropriate activities with average knee flexion of 120°, with 98% of patients reporting pain relief to be excellent, very good or good.
A survival analysis of patients in the trial indicated a cumulative success rate of 98.8% at 17 years, the company said.
It has been reported that approximately 20% of patients are not satisfied with the outcome of their total knee replacement.
“I am in my third year of using the Evolution Medial-Pivot Knee System and this publication validates the results that I have seen in my practice. In my experience, the functional outcomes for patients treated with this system have certainly been superior than the systems I’ve used in the past and patients have fewer complaints. When I see them at six or eight weeks follow-up, they’re at a different stage of recovery than I was seeing previously with traditional implant designs. I’ve been exceptionally happy with the results and feel comfortable knowing I am implanting a prosthesis with 98.8% survivorship at 17 years,” Dr. David Backstein of Toronto’s Mount Sinai Hospital said in a prepared statement.

FOR SALE: a proximal humerus plating system

Shoulder Options, Inc. is seeking to divest of its proximal humerus plate devices. The plating systems were designed for treatment of proximal humerus fractures and for rotator cuff repair, are 510(k) approved by the U.S. Food and Drug Administration (FDA), and have been granted utility and design patents by the U.S. Patent and Trademark Office (USPTO). The devices include the AFT™ Proximal Humerus Fracture Plate, the AFT™ Greater Tuberosity Fracture Plate, and the CRP™ Cuff Repair Plate.
“Shoulder Options has created innovative plating systems for anatomical repair of the proximal humerus,” commented T. Bradley Edwards, MD, of the Fondren Orthopedic Group in Houston, TX. Dr. Edwards, a member of the fracture plate design team, is recognized internationally as a leading author and speaker on orthopedic shoulder topics.
“Our devices were designed by a world-class team of orthopedic shoulder specialists,” said C. Scott Humphrey, MD, who is serving as the company’s interim CEO. “These plates have successful clinical track records, but our challenge as a small company has been achieving distribution on a larger scale. We hope to place our devices with a bigger company to make them accessible to more patients.”
Interested parties may visit the company’s website at http://www.shoulderoptions.com, or contact Dr. Humphrey at [email protected].

Medtronic wins temporary reprieve in ex-rep’s whistleblower suit

Medtronic wins temporary reprieve in ex-rep’s whistleblower suit (MassDevice)
Medtronic (NYSE:MDT) got a temporary reprieve this week in a whistleblower lawsuit brought by a former sales rep over its Verte-Stack spine implants
Bryan Shapiro, a former rep for Medtronic’s spine business, filed a whistleblower lawsuit in July 2016, alleging that Medtronic and its subsidiaries “engaged in a fraudulent scheme that caused the Medicare and Medicaid Programs to pay unlawful claims for payment” using a kickbacks scheme involving travel junkets dating back to 2000. The suit, filed in the U.S. District Court for Central California, also alleges that Medtronic “intentionally marketed devices without FDA approval, and trained and paid for physicians to train in implantation procedures with these devices.” The company was also accused of putting misbranded and adulterated implants on the market.
“As a result, defendants have reaped hundreds of millions of dollars selling the subject devices by skirting human testing required under a de novo or FDA’s most rigorous premarket approval (PMA) process to determine the safety and effectiveness device profile,” the lawsuit alleged. “These products have been involved in numerous reported adverse events, including those resulting in the need for revision surgeries, and including those resulting in paralysis and even death. Furthermore, defendants and defendants’ agents, including but not limited to hired surgeons and affiliated user-facilities, have routinely suppressed, misfiled, misreported and failed to file medical device reports (MDRs) as required.”
Medtronic moved to have the suit dismissed, countering that Shapiro “attempts to shoehorn a disparate series of allegations – many of which relate to so-called “off-label use” of Verte-Stack devices by physicians – into a False Claims Act cause of action.”
“It does not fit. The complaint applies conclusory labels and invokes irrelevant federal regulations in an effort to circumvent well-established law that off-label use of an FDA-approved or cleared product by a doctor is lawful. Neither off-label use by a physician nor the manufacturer’s promotion of such lawful uses can alone form the basis of FCA liability,” the company argued, according to court documents.
Shapiro’s assertion that the Verte-Stack devices were not eligible for reimbursement because of the alleged off-label promotion was off-base, Medtronic said.
“Despite the complaint’s assertions to the contrary, it is well-established that neither off-label use of a medical device, which is entirely lawful, nor so-called ‘off-label promotion’ by the manufacturer, standing alone, results in a false claim actionable under the FCA. Nor can [Shapiro] point to any material falsehood, an essential element of an FCA cause of action,” the company wrote in its motion to dismiss, adding that the 6-year statute of limitations also bar Shapiro’s claims.
Shapiro’s Anti-Kickback Statute claims “depend on the mistaken assumption that any payments made to a physician are per se illegal. The complaint fails to allege sufficient facts to support a plausible inference that Medtronic violated the AKS and that such violation led to a false claim,” Medtronic wrote in the motion.
Shapiro’s complaint is also not specific enough and its claims under the FDA’s conspiracy and “reverse false claims” provisions “are not supported by a single factual allegation,” according to the motion.
Judge John Kronstadt agreed in a Feb. 13 notice that he’s likely to dismiss the case.
“The court states its tentative views that it is inclined to grant without prejudice defendants’ motion,” Kronstadt wrote, ruling that Shapiro has until April 3 to file an amended complaint addressing any deficiencies.
Kronstadt also granted a joint request for 3rd-party settlement talks, giving the sides until Feb. 26 to agree on a neutral 3rd party and either set their own deadlines or ask the court to do it.

FDA triggers Zimmer Biomet recall of Reverse Shoulder due to high fracture rate

Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate (FDA)

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:

Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
Product Code: KWS, PAO
Lot Numbers: All lots with part number 115340; See full list of lot numbers
Distribution Dates: October, 2008 to September, 2015
Manufacturing Dates: August 25, 2008 to September 27, 2011
Devices Recalled: 3662

Device Use
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
Reason for Recall
Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Who May be Affected

Health care providers using this device during reverse shoulder replacement surgeries
Patients receiving total shoulder replacements using this device

What to Do
On December 20, 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice asked customers to:

Review the safety notice and ensure appropriate staff is aware of the notice.
Identify and quarantine any affected devices in stock.
The Zimmer Biomet sales representative will remove the affected device from the facility.
Complete and return the Certificate of Acknowledgement form within 3 days via email to [email protected].
Retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.

The notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.
Contact Information
Health care professionals and consumers with questions are instructed to contact the 411 Technical Services by phone at (574) 371-3071 or by email at [email protected] with any questions related to this recall.
Date Recall Initiated:
December 15, 2016
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
Lot Numbers:
041870 041880 041890 052860 060500 070330 079900 085130 118250 118260 118270 118280 118290 118300 118340 118350 118360 118370 118380 118390 132020 132030 153330 153340 153350 153360 153370 153380 153390 153400 153410 153420 153430 159650 159660 161960 172670 215990 216000 216010 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 310580 310590 310600 310610 310620 329390 349140 349150 351030 351040 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 385090 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424640 424650 424660 424670 424680 424690 424700 424710 424720 424730 424740 436760 436770 440500 457900 492370 492380 492390 492400 492410 492420 492430 492440 492450 501830 551660 556800 556820 557440 557620 557840 558840 558880 558890 558900 558910 558920 561910 562430 563440 568870 569050 569060 569070 569080 569090 569100 569120 569130 569140 569150 569690 578920 595090 597740 607390 607400 607410 607420 607430 609780 613990 630660 633600 634660 634860 635190 637190 637240 641220 641350 641390 641680 648790 648800 648810 648820 648830 648860 659950 659960 659970 659980 659990 660000 660010 660020 660030 660040 668550 668560 668570 668580 668590 668600 668610 668620 668630 668970 674320 677090 677100 677110 677140 677150 677160 677170 677180 677190 677200 680720 680730 680740 680750 680760 697100 697110 697120 697130 697150 697160 697170 697180 697190 697200 704050 704810 706840 712090 715990 716200 723830 723850 723870 723880 725550 725560 725760 726590 726710 734810 745350 762930 764700 765560 765830 765870 767360 767370 771810 788670 788680 788690 791260 791270 791280 818790 839150 846190 846200 846210 846230 846240 846280 846290 846300 846310 846320 846330 848110 848120 848130 848140 848150 848160 848170 848190 848200 848210 848220 848230 848240 848250 848260 848270 848280 848290 848300 848310 848320 854210 854220 854240 854250 854260 854290 854300 854310 854320 863330 889690 908010 950390 950400 963700 974990 981260 981270

Medical Device Recalls
2017 Medical Device Recalls2016 Medical Device Recalls

Analyst: Uptake for robotic knee procedures will depend more on marketing than evidence

The Medial-Pivot knee system is a winner in long term clinical results

FOR SALE: a proximal humerus plating system

Medtronic wins temporary reprieve in ex-rep’s whistleblower suit

FDA triggers Zimmer Biomet recall of Reverse Shoulder due to high fracture rate

Technology, Startup News, Career Advice & More

Archives

Pin It on Pinterest