interbody fusion procedures, which are performed to help alleviate pain and nerve compression by fusing and stabilizing adjacent
vertebrae in the lower back. The Expandable Interbody System is
designed to minimize the amount of implant insertion forces while
achieving the patient-specific anatomical fit needed for proper
treatment, according to the company. The system offers different
implant footprints, a range of implant height expansions and instrumentation, as well as in-situ height expansion and, if necessary,
the ability to reposition intraoperatively.
In September, the company introduced the Integra Freedom
Wrist Arthroplasty System in the United States. The Freedom
Wrist is an advanced implant design and includes enhanced instrumentation to aid in“efficient and potentially more reproducible surgical results,” officials said. The implant adds to the company’s upper extremity portfolio.
In July last year, the company completed its multicenter clinical
trial evaluating the safety and effectiveness of the Integra Dermal
Regeneration Template for the Treatment of Diabetic Foot Ulcers
(DFU). The data collected formed the foundation for the premarket
approval supplement application the company filed with the FDA in
February this year. An FDA approval with published data will form
the key to securing reimbursement. Assuming FDA approval and
timely publication of a peer-reviewed journal article, the company
plans to launch the resulting DFU product in the middle of 2016.
March saw the expansion of the company’s skin and wound
product line with the introduction of the Integra Wound Matrix
(Thin). Integra Wound Matrix (Thin) is a collagen-glycosamino-glycan wound matrix that maintains and supports a healing environment for wound management. Available in a variety of sizes, it
may be used for second-degree burns, partial and full-thickness
wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic
vascular ulcers, tunneled/undermined wounds, surgical wounds
(donor sites/grafts, post-Moh’s surgery, post-laser surgery, podi-atric, wound dehiscence), trauma wounds (abrasions, lacerations,
skin tears) and draining wounds. Terminally sterilized, Integra
Wound Matrix (Thin) can be stored at room temperature, has a
24-month shelf life, and is intended for one-time use.
Also in March, Integra rolled out its Laminoplasty System in
the United States. The system, which is used to treat patients with
ossification of the posterior longitudinal ligament, cervical myelopathy and degenerative spinal canal stenosis, is designed for use after open-door laminoplasty procedures in the cervical and thoracic
spine (C3-T3). The system encompasses a variety of arched plate
designs, self-drilling bone screws and multiple insertion options,
offering surgeons choices when treating patients with central canal
stenosis and myelopathy. The global laminoplasty market is estimated to reach approximately $70 million by 2015. With the addition of the Laminoplasty System, Integra is well positioned to gain
a key foothold in this rapidly growing market.
Integra LifeSciences introduced its line of titanium bone
wedges, designed for internal fixation for bone fractures or os-
teotomies in the foot and ankle, in February. The wedges may be
used in corrective procedures, such as Cotton (opening wedge)
osteotomies of the medial cuneiform and Evans lengthening
osteotomies. They are composed of commercially pure titanium
formed into a cancellous-like structure that mimics the strength
and porosity of human bone. The system is available in 15 differ-
ent pre-shaped anatomical sizes, to accommodate various skel-
etal deformities in the foot. Osteotomies are procedures in which
surgeons realign or remove a segment of bone located near a
damaged joint to help correct deformities, typically in the foot.
Bone wedges are designed to provide bone-grafting material for
osteotomy corrections. They provide a scaffold for bone growth,
as well as biologic stability and structural support for deformity
corrections. Ancillary plates are used to hold bone graft material
in place and prevent it from expulsion.
More of a manufacturing milestone than a product development one, Integra wrapped up an ongoing FDA issue at its facility in
Añasco, Puerto Rico. Following FDA inspections in the fall of 2012,
the agency issued a warning letter for the facility in February 2013.
On Nov. 26, 2013, the FDA completed its second inspection of the
Añasco facility and issued a new Form 483 with six additional observations. On Sept. 30, 2014, the FDA completed its third inspection
of the facility, and concluded that the company had addressed the
issues raised in the warning letter and previous inspectional observations, and it issued no other inspectional observations. The Añasco
warning letter was closed out effective Jan. 14 this year.
Magic No. 11
The company grew revenue 11 percent to $928 million. Domestic revenues increased 11 percent to $714.0 million and were 77
percent of total revenues for the year. International revenues also
increased 11 percent to $214.3 million. Foreign exchange fluctuations had a negative impact of $2.3 million on annual sales. Net
income was $34 million, up from a loss of $21 million for FY13.
U.S. Neurosurgery revenue was $244.6 million, an increase of 42
percent, largely the result of DuraSeal product sales arising out of
the Confluent Surgical acquisition, which added $54.1 million in
the period. Revenue for the U.S. Instruments division was $157.8
million, a decrease of 4 percent from the prior year. According
to the company, lower sales were the result of sluggish sales in
the acute-care and alternate-site businesses and product discontinuations. A partial-year contribution from Integra’s purchase of
Medtronic’s MicroFrance in October partially offset the decline.
Sales for U.S. Extremities were $143.4 million, an increase of 12
percent—mostly due to strong sales of dermal and wound-care
products, including the company’s “thin” version of its Integra
Wound Matrix, and from its shoulder product line, which increased as a result of the launch of a new reverse shoulder and increases in the number of distributors selling the technology. The
remainder of the company’s lower and upper extremity franchise
increased slightly during the period partially as a consequence of
sales force turnover in the second quarter of 2014 as well as the
transition to a new total foot system, officials reported. U.S. Spine
division revenue, which includes spine hardware, orthobiologics
and private-label products, were $171.4 million, a decrease of 6
percent. Sales of spine hardware softened due to ongoing pricing
pressure, delays in expected product launches, and slower than