Restorative Therapies Group
The Restorative Therapies Group is composed of the Spine, Neuromodulation, and Surgical Technologies businesses. Products in the Restorative Therapies Group include products for various areas of the spine, bone graft substitutes, biologic products, trauma, deep brain stimulation (DBS) implantable neurostimulation therapies and drug delivery systems for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, fecal incontinence and gastroparesis, products to treat conditions of the ear, nose, and throat, and systems that incorporate advanced energy surgical instruments. Additionally, this group manufactures and sells image-guided surgery and intra-operative imaging systems. The Restorative Therapies Group’s net sales for the three months ended July 26, 2013 were $1.554 billion, an increase of 2 percent over the same period in the prior fiscal year. Foreign currency translation had an unfavorable impact on net sales for the three months ended July 26, 2013 of $16 million compared to the same period in the prior fiscal year. The Restorative Therapies Group’s performance was favorably impacted by strong net sales in Surgical Technologies and growth in
Neuromodulation, partially offset by declines in Spine, primarily driven by BMP (composed of INFUSE bone graft (InductOs in the European Union) sales). See the more detailed discussion of each business’s performance below.
Spine net sales for the three months ended July 26, 2013 were $765 million, a decrease of 3 percent over the same period in the prior fiscal year. The decrease in Spine's net sales was primarily driven by a decline in BMP sales of 12 percent over the same period in the prior fiscal year in addition to unfavorable foreign currency translation. Significant declines in U.S. sales of INFUSE bone graft have continued since the Ju
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2011 articles in The Spine Journal, as further described below. Core Spine net sales declined 1 percent primarily driven by negative performance in balloon kyphoplasty (BKP). Net sales in BKP declined 11 percent when compared to the same period in the prior fiscal year due to competitive pricing pressures and reimbursement challenges with select payers. The decline in BKP was substantially offset by recent launches of our new products and therapies, including the launch in the second quarter of fiscal year 2013 of AMT implants and the BRYAN artificial cervical disc, as well as the continued adoption of Solera and other biologics products. The U.S. Core Spine market continued to show signs of stabilization with flat procedural volumes and product mix. Core Spine has also benefited from our focus on enabling technologies, including the O-Arm imaging system, StealthStation navigation, and Powerease powered surgical instruments. Our Kanghui orthopedics business in China continues to perform well and offset the revenue from our former joint venture with Shandong Weigao Group Medical Polymer Company Limited.
Neuromodulation net sales for the three months ended July 26, 2013 were $428 million, an increase of 2 percent over the same period in the prior fiscal year including unfavorable foreign currency translation. The increase in net sales was primarily due to solid global growth in sales of our DBS systems for movement disorders and InterStim Therapy for overactive bladder, urinary retention, and bowel incontinence, partially offset by declines in U.S. implant procedural volumes for our non-MRI spinal cord stimulation systems. We received U.S. FDA approval for our conditionally safe SureScan MRI system earlier than anticipated and transitioned manufacturing in the first quarter of fiscal year 2014 to the SureScan MRI system, resulting in supply constraints on both the non-MRI and MRI stimulators. Additionally, certain customers deferred procedures until the SureSc
SureScan MRI system is available. Full launch of the SureScan MRI system will occur in the second quarter of fiscal year 2014.
Surgical Technologies net sales for the three months ended July 26, 2013 were $361 million, an increase of 11 percent over the same period in the prior fiscal year. The increase was driven by continued worldwide growth across the portfolio of ENT, Power Systems, and Advanced Energy, partially offset by unfavorable foreign currency translation. The performance included strong sales of StealthStation S7 surgical navigation systems and image guided surgery, monitoring, and balanced growth of disposables. Additionally, net sales were positively impacted by the successful launch in the second half of fiscal year 2013 of the Trivantage EMG tube in Europe and the U.S., and the Indigo high-speed otologic drill in the first quarter of fiscal year 2014.
Looking ahead, we expect our Restorative Therapies Group could be affected by the following:
• Changes in procedural volumes, competitive and pricing pressure, reimbursement challenges, impacts from changes in the mix of our product offerings, and fluctuations in foreign currency.
• Market acceptance and continued adoption of innovative new products, such as our Solera product line, Bryan ACD Instrument Set, and other biologics products, including MAGNIFUSE and GRAFTON products, and POWEREASE, a powered instrument solution for Solera.
• Market acceptance and continued market penetration of BKP. We remain focused on generating evidence to better demonstrate the clinical and economic benefits for BKP. We will continue to tailor our BKP product offering to meet market needs and respond to competitive challenges. We anticipate additional continued pricing pressures and competitive alternatives in the U.S. and European markets.
• Spine sales continue to be negatively affected by the June 2011 articles in The Spine Journal, and by the reaction from inquiries by governmental authorities, relating to our INFUSE bone graft product. The Spine Journal articles suggested that some physicians' peer-reviewed studies may have underreported complications and adverse events associated with INFUSE. These articles did not question the integrity of the data provided by Medtronic to the U.S. FDA for product approval or the disclosure of safety issues on the product's Instructions for Use for approved indications. In August 2011, we provided a grant to Yale University to oversee two independent, systematic reviews of data from completed clinical studies of INFUSE bone graft, as well as data from other Medtronic studies of rhBMP-2, the protein used in INFUSE. Yale independently assembled a panel of experts and commissioned Oregon Health & Sciences University and University of York in the United Kingdom to conduct the analyses of the data. The two systematic reviews, which were summarized in articles published in the Annals of Internal Medicine in June 2013, concluded, among other things, that INFUSE is an effective therapy in certain types of spine surgery, and that INFUSE entails a number of risks that should be considered by physicians and patients. Looking ahead, the Company expects continued scientific and clinical