4. A section is cut away, then the process is repeated for the
joint’s other bone.
5. The artificial joint fits neatly where the cuts were made
into the bone. Surgery is quickened because time spent
figuring out where to cut into the bone is removed.
It hasn’t been fully determined what benefit this translates to
for patients, however. Increasing precision with 3D printing may
reduce operating time, but could add about $1,000 to the surgery’s
cost, according to Dr. Jason Koh, an orthopedic surgeon in Illinois
at NorthShore University Health System. “It does seem like custom cutting guides can definitely improve implant position, but
there is clearly some cost associated with it, and since our existing
technologies do very well, it’s going to take some time to demonstrate long-term benefit,” Koh commented to the Union-Tribune.
Netherlands-based Wright Medical probably isn’t worrying
too much about the cost of anything right now; the company
generated $415.6 million in sales in fiscal year 2015 (ended Dec.
27), an impressive 39. 4 percent growth from the year prior. The
majority of this increase was attributed to a landmark merger
with Tornier N.V., which officially closed Oct. 1, 2015, with the
all-stock deal valued at $3.3 billion. The merger has ushered in
a milestone that Wright President and CEO Robert Palmisano
dubbed“the New Wright Medical.”
“The culmination of this merger marks a significant milestone
for our company, creating the premier, high-growth Extremities-
Biologics company uniquely positioned with leading technolo-
gies and specialized sales forces in three of the fastest growing
areas of orthopedics—Upper Extremities, Lower Extremities, and
Biologics,” Palmisano stated in the company press release an-
nouncing the merger’s completion.
Tornier brought an extensive portfolio of joint replacement and
soft tissue repair technologies for the upper extremities. As expected,
the merger with Tornier fortified Wright’s upper extremities business
quite significantly in FY15. Though not the company’s main source
of revenue, it’s certainly headed north—upper extremities sales in
the United States totaled $58.7 million, and international sales totaled $24.8 million, respectively soaring a whopping 283.8 and 119.1
percent over the previous year. In total, the company’s upper extremities business gained $60.6 million from Tornier products acquired in
the merger. U.S. Food and Drug Administration (FDA) clearance of
Tornier’s Simpliciti Shoulder System in March 2015 further added
to the product anthology. Simpliciti is a bone sparing total shoulder
arthroplasty system with an ultra short-stem design without a metal
implant extending into the distal humeral canal, which reduces risk
of a mid-shaft humerus fracture following implantation.
Though somewhat dwarfed by the double and near tripling
of the upper extremities business, the effects of the merger were
still felt on the rest of Wright’s business divisions to a lesser—but
still significant—extent. Sales for FY 2015 in the lower extremities
business (the company’s main revenue source) reached $187.1
million in America and $51.2 million internationally, growing 25. 9
and 8. 9 percent respectively. Lower extremities assets gained in
the merger were responsible for $9.2 million of the sales increase
globally, but a number of new and established products featured
during the 2015 American Academy of Orthopaedic Surgeons
(AAOS) Annual Meeting had parts to play in the increase:
• The INFINITY Total Ankle Replacement (TAR) System
continued to reinforce Wright’s arsenal of Total Ankle
replacement offerings with a lower profile design and
straightforward surgical approach.
• Product line extensions for the INBONE TAR System,
which broaden options for surgeons with a smaller talar
dome for patients with small anatomy. Uncoated tibia
stems and a revision poly insert were also introduced.
• The aforementioned PROPHECY Pre-Operative Navigation Alignment Guides, to precisely size, place, and align
INFINITY and INBONE TAR components.
• A flatfoot osteotomy solution, OTHOLOC 3Di Flatfoot
plates feature 3Di medial displacement calcaneal osteotomy plating.
• 510(k) clearance of the SALVATION External Fixation
System—designed to address fractures, nonunions, and
complex foot and ankle deformities.
The September, FDA approval of AUGMENT Bone Graft—an al-
ternative to autograft to ankle and/or hindfoot fusion procedures—
added another therapeutic option to Wright’s Biologics repertoire.
According to Dr. Christopher DiGiovanni, lead U.S. investigator for
AUGMENT’s North American pivotal trial and chief of the Foot and
Ankle Service in the Department of Orthopaedic Surgery at Massa-
chusetts General Hospital, Harvard Medical School, “...AUGMENT
offers clear patient benefit by enabling a healing rate and safety
profile equivalent to autogenous bone graft—while simultaneously
avoiding the additional surgery required to harvest autograft bone
graft tissue that can result in site-specific complications and/or pro-
longed harvest site pain in some patients.”
AUGMENT sales in the fourth quarter of 2015 contributed to
an 11.2 percent growth in U.S. Biologics sales, producing $50.6
million in revenue. Although AUGMENT’s international sales
performed admirably, they could not offset volatile foreign cur-
rency, which precipitated a 5 percent loss (Wright’s only segment
reporting a decline) from the previous year with $19.6 million
in sales. Sports medicine and other products drew $13.2 mil-
lion globally in 2015, a 36 percent growth from 2014. Wright also
added a new product category to its offerings in 2015 due to the
merger with Tornier, in the form of a“large joint” segment. 2015
global sales of large joint products totaled $10.1 million.
As of Jan. 30, 2016, 1,126 lawsuits were pending in the MDL
and JCCP pertaining to Wright’s metal-on-metal hip products,
mostly in the company’s CONSERVE line. The first MDL bellwether trial began on Nov. 9, 2015, and culminated in favor of the
plaintiff, who was awarded $11 million total in compensatory and
punitive damages. However, the company believed “there were
significant trial irregularities” and contested the result. Wright
filed a post-motion for a new trial or reduction of damages, which
is still pending. v