Merit is pleased to participate this year at GEST. In addition to showcasing products, we are pleased to provide several hands-on learning opportunities. PAE Learning Pavilion Merit will host the Prostatic Artery Embolization (PAE) Learning Pavilion at GEST, featuring simulators with actual PAE cases designed by Dr. Shivank Bhatia. These innovative and realistic simulators feature […]
The success of percutaneous vertebral augmentation (PVA) relies on the quality of its bone cement. To relieve the pain that accompanies pathologic vertebral compression fractures, cement must be injected into affected vertebra with precision and control. To accomplish this, Merit Medical launched its proprietary StabiliT Bone Cement that offers physicians two significant advantages over other cements on the market.
“There are multiple factors that contribute to StabiliT Bone Cement’s advantages from my perspective as a treating clinician: extended working time and increased viscosity,” says Jayson S. Brower, MD, Radiologist at Inland Imaging Associates and Providence Sacred Heart Hospital in Spokane, WA. “With StabiliT cement, you have more control. Increased working time allows you to take your time. Because of its viscosity, you have more confidence in where you’re putting the cement into the bone.”
Using conventional high-viscosity bone cement often translates into shorter working times. Merit’s StabiliT Bone Cement maintains its high-viscosity with a working time of 35-minutes. When used with the original StabiliT Vertebral Augmentation System, higher levels of radiofrequency (RF) energy are initially applied to the cement to increase its viscosity but then taper off over the length of the procedure. This allows control of the polymerization, making the delivery of high-viscosity cement over an extended working time possible.
Maintaining this viscosity has its clinical benefits especially when managing common complications like cement extravasation. According to Dr. Brower, whether a physician is treating pathologic fractures or osteoporotic fractures, cement potentially leaking outside of the vertebral body is a widespread concern but one that a highly viscous cement can ameliorate.
“Because of StabiliT’s increased viscosity, you have confidence that this cement is far less likely to leak,” Dr. Brower explains. “If you have large fracture planes or are treating pathologic fractures due to vertebral metastatic tumors, you’re potentially concerned about cement leakage. For example, when there’s disruption of the posterior aspect of the vertebral body that reaches into the spinal canal, using StabiliT Bone Cement offers a huge advantage.”
What’s more, using bone cement that retains a high viscosity over the length of a procedure affords time to address or even revisit areas of concern. “StabiliT’s prolonged working time allows you to install a bit of cement, let it set up, go back, and place additional cement,” Dr. Brower continues. “Or if you don’t get the optimal spread, you can go back, form additional channels, and place additional cement in that same level.”
To offer these same benefits to physicians with varying clinical needs and patient requirements, Merit introduced the StabiliT MX Vertebral Augmentation System—a simplified system that only requires the use of a precision syringe to deliver high-viscosity cement.
“A great opportunity for the MX system would be in an outpatient practice, treating in an ambulatory setting,” Dr. Brower notes. “The lower cost, combined with increased control of the StabiliT Cement, would be a huge advantage. It could give a clinician the chance to use a potentially more expensive system in a cost-effective way and leverage the safety and efficacy of the MX cement in that outpatient setting.”
Limited working time and unreliable cement viscosity have often left physicians rushing to complete a procedure. StabiliT Bone Cement’s versatility and many clinical advantages, mainly its extended working time and dependable high-viscosity, have made it the bone cement of choice.
“I’ve used just about everything on the market and, through trial and error, I’ve realized there’s nothing quite like it. I use StabiliT Bone Cement exclusively,” Dr. Brower adds. “I think the clinical advantages warrant its use.”
Alicia Armeli and Dr. Brower are paid consultants of Merit Medical. For more information please refer to Instructions for Use. Consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.
Thirty years ago, the first-generation percutaneous vertebral augmentation (PVA) system was introduced for the management of painful pathologic vertebral compression fractures. Since then, PVA treatment has had dramatic improvements in both bone cement formulations and delivery systems.
For example, higher cement viscosity has been considered desirable in recent years, but as viscosity increases, working time decreases. Therefore, conventional high-viscosity cements, with relatively short working times, often result in cement clogging the delivery system prior to the physician completing a procedure.
To address such challenges head on, Merit Medical’s portfolio of StabiliT Bone Cement with expanded delivery options in the StabiliT Vertebral Augmentation Systems has two main advancements over the competition: 35-minutes extended working time with remotely controlled delivery and trusted high-viscosity bone cement.
Merit’s unique proprietary StabiliT Bone Cement formulation offers physicians time flexibility to do a procedure in a controlled fashion, regardless of its complexity and number of levels requiring treatment. Physicians can also routinely initiate procedures with a unipedicular approach and still have adequate working time to convert to a bipedicular procedure, if required, avoiding the need to rush or mix additional cement.
Complex procedures that necessitate extended working time can also depend on StabiliT Bone Cement maintaining its high-viscosity. Bone cement viscosity has been shown to correlate to procedural success. How bone cement interacts with the fractured vertebral body determines how the cement stabilizes a fracture and/or extravasates (leaks).1 In an ex-vivo assessment of vertebral augmentation procedures, Lador et al. noted that several factors, specifically cement viscosity and rate of delivery, could influence cement flow within and leakage out of the vertebral body.1,2 Georgy reported approximately 50% less cement leakage using a controlled delivery of ultra-high viscosity cement after cavity creation with an osteotome compared to a lower viscosity cement in balloon kyphoplasty cases.3
In the original StabiliT Vertebral Augmentation System, proprietary ultra-high viscosity bone cement is heated with radiofrequency (RF) as it passes through a warming cartridge and its polymerization is accelerated just prior to being delivered into the vertebra. The controller’s software algorithm applies more RF energy initially to rapidly increase the cement viscosity and then less as time goes on, enabling the delivery of the same ultra-high viscosity over an extended working time. Delivery of this ultra-high viscosity cement is remotely controlled by the physician at an optimized delivery rate.
In response to some physicians desiring this same control but in a simplified design, Merit launched the StabiliT MX Vertebral Augmentation System. The StabiliT MX uses high-viscosity bone cement that has the same clinical benefits and same 35-minute extended working time, but it doesn’t require a controller or RF energy. The StabiliT MX provides high-viscosity cement that’s hand delivered using an ergonomic precision syringe.
The StabiliT MX delivery syringe contains a quick release clutch mechanism that allows for immediate cement flow stoppage. The use of a 3-foot hydraulic line increases the distance from which cement is conventionally hand delivered, helping to minimize a physician’s radiation exposure.4 Other features include a unique vacuum-based mixing system and articulating instrumentation for site and size specific cavity creation.
PVA treatment has been shown to significantly relieve pain of vertebral compression fractures.5 Merit is committed to providing technology that gives physicians maximum control as well as flexibility in cement and delivery options in order to optimize patient care. By using Merit’s trusted cement and simplified delivery systems, why not bring these benefits to your practice?
Alicia Armeli is a paid consultant of Merit Medical. For more information please refer to Instructions for Use. Consult product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.
- Lador, R., Dreiangel, N., Ben-Galim, P., et al. (2010). A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J, Dec; 10(12): 1118-1127.
- Loeffel, M., Ferguson, S. J., Nolte, L. P., et al. (2008). Vertebroplasty: experimental characterization of polymethylmethacrylate bone cement spreading as a function of viscosity, bone porosity, and flow rate. Spine, May; 33(12):1352–1359.
- Georgy, B. (2013). Comparison between radiofrequency targeted vertebral augmentation and balloon kyphoplasty in the treatment of vertebral compression fractures: addressing factors that affect cement extravasation and Pain Physician, Sept-Oct; 16(5): E513-518.
- Radiology Masterclass. (n.d.). Basics of X-Ray Physics. Retreived from http://www.radiologymasterclass.co.uk/tutorials/physics/x-ray_physics_safety
- Mpotsaris, A., Abdolvahabi, R., Hoffleith, B., et al. (2011). Percutaneous vertebroplasty in vertebral compression fractures of benign or malignant origin: a prospective study of 1188 patients with follow-up of 12 months. Dtsch Arztebl Int, May; 108(19): 331-338.
By Alicia Armeli
Each year, 400,000 people in the US alone suffer from bone metastases.1 Frequently seen in the spine—and specifically in the vertebrae—spinal tumors make up 40% of all bone metastatic disease.2,3 Pain associated with this condition can be excruciating.
Merit Medical’s STAR™ Tumor Ablation System (Spinal Tumor Ablation with Radiofrequency)—a unique device designed for the palliative treatment of painful metastatic spinal tumors—has been found to significantly reduce patient reported pain, often decreasing the need for pain medications, and improving overall quality of life.3,4
Historically, treating patients with metastatic spinal tumors has been a challenge. Traditional pain management is a balancing act that involves pain control, local tumor control to avoid neurological damage, and mechanical stabilization to preserve function.2 Treatments include pain medicines, chemotherapy, radiation therapy, and/or surgery. However, surgery may be avoided due to coexisting health problems or diminished life expectancy.3
A minimally invasive alternative that has been found to successfully treat spinal metastatic lesions is targeted radiofrequency ablation with the STAR Tumor Ablation System. Recognized in version 2014 of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Adult Cancer Pain as an interventional strategy for treatment of local bone pain, radiofrequency ablation can provide rapid pain relief by localized tumor destruction—often in a single outpatient session.5
Anchala et al. conducted a multicenter retrospective study of the STAR Tumor Ablation System involving 92 patients with a total of 128 metastatic spinal lesions from five academic centers who underwent targeted radiofrequency ablation between March 2012 and March 2013.3 Results published in Pain Physician Journal reported all 96 procedures to be technically successful without complication or thermal injury. Average Visual Analogue Scale (VAS) Scores showed that reported pain reduced significantly from 7.51 out of 10 before the procedure to 1.73 post-procedure, which stayed consistent at 6 months (1.75).
What’s more, the authors noted that 54% of the patients participating at the largest center were able to decrease their pain medication dosage. At the same center almost two-thirds of the lesions treated with the STAR Tumor Ablation System were located in the posterior vertebral body—a location previously considered difficult to access. Post ablation images confirmed the size of ablation zones matched those measured with device feedback and showed no further growth or canal extension of treated tumor.
Also significant to note, the STAR Tumor Ablation System was able to treat these patients without having to interrupt their primary cancer treatment. “For late-stage cancer patients, extreme back pain due to spinal tumors degrades quality of life; and until now, limited minimally invasive procedural options for immediate pain relief have been available,” said Nam D. Tran, MD, PhD, a neuro-oncology surgeon at Moffitt Cancer Center, Assistant Professor of Oncology and Neurosurgery at the University of South Florida College of Medicine in Tampa, Fla., and co-author of the study. “This multi-center study validates t-RFA (targeted radiofrequency ablation) as a treatment option that provides rapid, lasting pain relief without the need to interrupt the patient’s primary cancer therapy.”6
The STAR Tumor Ablation System procedure begins with a small puncture at the desired access site and the SpineSTAR® device is inserted into the affected vertebra by way of a working cannula. Active steering capability of the ablation instrument allows for precise navigation through the pedicle and into the desired areas of the vertebra-containing tumor. Once in place, radiofrequency energy is emitted through a bipolar electrode resulting in thermal necrosis of the adjacent tissue while two thermocouples on the electrode simultaneously monitor the tissue temperature. This real time feedback gives physicians the control to create site-specific ablation zones. The radiofrequency energy administration is stopped once the proximal thermocouple measures 50°C . When clinically indicated, the SpineSTAR device allows for precise repositioning within the vertebral body to produce overlapping ablation zones.
An advantage radiofrequency ablation therapy has is that it’s effective on its own and can also be used in conjunction with other treatments. Whether this means patients can continue their prescribed cancer regimen uninterrupted—as noted in the aforementioned study—or as part of a synergistic approach to pain management, ablation has the advantage of flexibility. Coupling pain management therapies can benefit patients with pain that’s hard to manage using traditional forms of treatment, such as radiation therapy.
Although a conventional course of radiation therapy delivered over a series of days to weeks is considered standard care for persistent pain, it has its drawbacks. Statistics show that approximately 60% of patients obtain partial pain relief and only 32% of patients respond with complete palliation.7 Additionally, pain relief following radiation therapy isn’t immediate and can take several weeks.2 Moreover, radiation treatment does have dosage limits. Once dose thresholds of the adjacent normal tissue, such as the spinal cord in the case of spinal metastatic lesions, have been met, recurrent pain at a previously treated site often can’t be retreated.2
A previous feasibility study suggested that combining radiation and ablation therapies may work together to achieve better outcomes compared to using each as a standalone treatment.8 The effect of combined treatments on metastatic spinal tumors was recently reported by Greenwood et al. who carried out a retrospective study, which analyzed medical records of 21 patients with 36 metastatic spine lesions—including radioresistant tumors—treated with the combination of radiation therapy and targeted radiofrequency ablation using the STAR Tumor Ablation System between March 2012 and June 2014.2
Post-procedure outcomes showed patient reported pain measured with the numerical rating scale (NRS) to decrease significantly from an average 8 out of 10 pre-treatment to 4.3 at 1-week and 2.9 at 4-weeks post-treatment. Opioid pain medication use also reduced in 62% of the patients and general activity level increased in 81% of patients at a 4-week follow-up. Post-procedural imaging showed stable treated disease in 12 of 13 and 10 of 10 patients at 3- and 6-months, respectively.
Based on these findings, the authors considered it effective to use ablation and radiation therapies together to treat pain in patients with metastatic spinal lesions and could be an option for those with radiation resistant tumors.
From its start in 1992 treating a handful of patients with benign bone tumors, radiofrequency ablation therapy transformed into an established method of treating metastatic bone disease.3
Almost two decades later in 2012, following FDA 510(k) clearance, DFINE Inc. introduced a percutaneous radiofrequency ablation device purpose built for the palliative treatment of spinal metastatic lesions. Acquired by Merit Medical earlier this year, DFINE Inc. and its unique line of medical devices—including the STAR Tumor Ablation System—are now a part of Merit’s growing portfolio of state-of-the-art oncology products.
It’s estimated that half or more of cancer patients may experience bone pain.1 Metastatic bone lesions are exceedingly common among these individuals and have been found to be the most prevalent cause of chronic pain in this population.3 These tumors have been seen in up to 80% of cancer patients at the time of death, with spinal metastases occurring in about 50% of these cases.3
The STAR Tumor Ablation System can be an option for these patients by offering rapid relief and improved quality of life.4 “If you look at a lot of the treatments that are used [to treat metastatic spine tumor pain], quality of life and life expectancy are not included. And they should be factored in,” explained Jack Jennings, PhD, MD, Diagnostic Radiologist, Associate Professor of Radiology at the Washington University School of Medicine, and Director of Musculoskeletal and Spine Interventions at Mallinckrodt Institute of Radiology in St. Louis, Mo. “Daily we physicians see these patients suffering with pain that has dramatically affected the life they have left.”9
- Smith, H. (2011). Painful osseous metastases. Pain Physician, 14(4): E373-405. http://www.painphysicianjournal.com/linkout?issn=1533-3159&vol=14&page=E373
- Greenwood, T., Wallace, A., Friedman, M., Hillen, T., Robinson, C., & Jennings, J. (2015). Combined ablation and radiation therapy of spinal metastases: a novel multimodality treatment approach. Pain Physician, 18(6): 573-581. http://www.painphysicianjournal.com/current/pdf?article=MjQ1Mg%3D%3D&journal=92
- Anchala, P., Irving, W., Hillen, T., Friedman, M., Georgy, B., Coldwell, D., Tran, N., Vrionis, F., Brook, A., & Jennings, J. (2014). Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study. Pain Physician, 17(4): 317-327. http://www.painphysicianjournal.com/current/pdf?article=MjEyOA%3D%3D&journal=83
- Bagla, S., Sayed, D., Smirniotopoulos, J., Brower, J., Neal Rutledge, J., Dick, B., Carlisle, J., Lekht, I., & Georgy, B. (2016). Multicenter prospective clinical series evaluating radiofrequency ablation in the treatment of painful spine metastases. CardioVascular and Interventional Radiology, 39(9): 1289-1297. doi: 10.1007/s00270-016-1400-8. https://www.ncbi.nlm.nih.gov/pubmed/27343124
- National Comprehensive Cancer Network. (2016). NCCN Guidelines. Retrieved October 18, 2016 from https://www.nccn.org/professionals/physician_gls/f_guidelines.asp
- Merit Medical Systems Inc. (2014). Press Release: Multi-Center Trial Shows Significant Pain Relief For Spine Cancer Patients Following Targeted Radiofrequency Ablation Treatment. Retrieved October 20, 2016 from, https://www.merit.com/category/press-release/
- Sze, W., Shelley, M., Held, I., & Mason, M. (2004). Pallation of metastatic bone pain: single fraction versus multifraction radiotherapy – a systematic review of the randomised trials. The Cochrane Database of Systematic Reviews. (2): CD004721. https://www.ncbi.nlm.nih.gov/pubmed/15106258
- Di Staso, M., Zugaro, L., Gravina, G. L., Bonfili, P., Marampon, F., Di Nicola, L., Conchiglia, A., Ventura, L., Franzese, P., Gallucci, M., Masciocchi, C., Tombolini. V. (2011). A feasibility study of percutaneous radiofrequency ablation followed by radiotherapy in the management of painful osteolytic bone metastases. European Radiology, 21(9): 2004-2010. doi: 10.1007/s00330-011-2133-3. https://www.ncbi.nlm.nih.gov/pubmed/21533865
- Merit Medical Systems Inc. (2016). STAR™ Tumor Ablation System. Retrieved October 17, 2016, from https://www.merit.com/interventional-oncology-spine/spine-ablation/ablation/star-tumor-ablation-system/
Alicia Armeli is a Freelance Writer and Editor who specializes in medical technology, health, and wellness.
As an interventional neuroradiologist, Dr. Amish Doshi, Associate Professor of Radiology and Neurosurgery, Chief of Neuroradiology and the Director of Spine Imaging and Interventions at the Mount Sinai Hospital in New York City, has had the opportunity to treat a variety of disorders of the head, neck and spine. Throughout his career, he has developed a special interest in the diagnosis and treatment of spine disorders through both imaging interpretation and spinal interventional procedures.
After years of observing benefits for his patients, he chooses to focus on vertebral augmentation and radiofrequency ablation to treat spinal fractures and spinal tumors. With improvements in cement viscosity, navigational instrumentation and use of radiofrequency technology, especially in the field of spinal tumor treatment, Dr. Doshi has increased his focus on the treatment of local tumor control and pain palliation in the setting of metastatic disease to the spine.
Dr. Doshi will imbue his knowledge of and experience in targeted vertebral procedures later this week at the Interventional spine training course hosted by Merit Medical at Mount Sinai. During the course, physicians will gain hands-on cadaver experience with the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System.
Other program faculty members include Dr. Reade De Leacy, Director of Neurointerventional Spine for Mount Sinai Hospital: Dr. Ramsey. Abadir, Chairman of Radiology and Director of Interventional Radiology, Orange Regional Medical Center in Middletown, NY; Dr. Michael Hallisey, Chief, Vascular & Interventional Radiology, Hartford Hospital, Hartford, CT; Dr. Avi Beck, Quantum Imaging and Therapeutic Associates, Lewisberry, PA; and Jennifer Merhar, R.N., Jefferson Radiology, Outpatient IR Center, Hartford, CT.
Merit Medical plans to announce its 2017 schedule for Interventional spine training courses in the coming weeks. To learn more, visit Merit.com/PEC.
September 17th, 2017
Merit Medical hosted 12 physicians for a Physician Education Course on minimally invasive vertebral therapies on Saturday, September 17th, 2017 at Washington University in St. Louis. The Physician Education Course program is a focused cadaver lab workshop designed to deliver detailed information on appropriate use of Merit’s technology and the minimally invasive procedures of vertebral augmentation, vertebroplasty and spine tumor ablation, using Merit’s StabiliT® Vertebral Augmentation Systems and the STAR™ Tumor Ablation System. Expert faculty is chosen to present the supporting clinical data and share their tips and tricks.
To learn more or sign up for a future course visit https://www.merit.com/pec/
SOUTH JORDAN, Utah, July 06, 2016 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has acquired DFINE, Inc. headquartered in San Jose, California, in a merger transaction through which DFINE has become a wholly-owned subsidiary of Merit.
The purchase consideration was approximately $97.5 million in cash and was financed by a group of banks led by Wells Fargo and included Bank of America, HSBC and U.S. Bank.
DFINE produced revenues of $33.4 million in 2015, with approximately 75% of revenues generated in the United States and 25% outside the United States. DFINE’s products are directed to vertebral augmentation (kyphoplasty and vertebralplasty), as well as targeted radiofrequency ablation of metastatic spinal tumors. DFINE’s product lines have 510(k) clearance and CE marking.
“We are delighted to have DFINE join Merit,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Our relationship began a few years ago when Merit was asked to provide key device components for DFINE’s StabiliT® and StabiliT MX® products. In addition to the spinal compression fracture segment, we believe DFINE’s Star™ Tumor Ablation Kit complements and enhances Merit’s oncology business.”
“We plan to combine Merit’s oncology segments, including embolics, microcatheters and biopsy products into a newly created interventional oncology and spine division (IOS),” Lampropoulos said. “We believe the restructuring of the sales divisions – cardiovascular, peripheral and IOS – will enable us to devote greater focus on Merit’s broad portfolio of products, align our sales and marketing efforts with Merit’s goal of achieving a more therapeutic and disease state centered product offering, and enhance opportunities for future growth.”
“We believe the opportunity for growth with these best-in-class products is substantial in the United States and also in international markets where Merit already has a broad footprint,” Lampropoulos continued. “Although DFINE has a presence in Germany and Austria, as well as limited distribution partners, we believe there are many opportunities in Australia, Canada, Japan, China, the Nordic countries and other regions. We anticipate that DFINE’s IP portfolio of approximately 110 U.S. and international patents will provide substantial coverage for many years ahead.”
The effect of the DFINE acquisition on Merit’s non-GAAP earnings for the balance of 2016 is expected to be neutral due to business restructuring and consolidation expenses and is expected to be dilutive on a GAAP basis by $0.24-$0.26 per share due to intangible amortization and one-time reorganization costs. In 2017, Merit anticipates the effect of the acquisition on Merit’s non-GAAP earnings to be $0.05-$0.08 per share and to be dilutive on a GAAP basis by $0.05-$0.07 per share. Merit believes the acquisition will increase its gross margin by approximately 80 basis points on a non-GAAP basis and 55 basis points on a GAAP basis.
Canaccord Genuity acted as Merit’s financial advisor for this transaction. Piper Jaffray acted as DFINE’s financial advisor.
CONFERENCE CALL TODAY Merit invites all interested parties to participate in its conference call discussing the acquisition (conference ID 41983902) today, Wednesday, July 6, 2016, at 11:00 a.m. Eastern (10:00 a.m. Central, 9:00 a.m. Mountain, and 8:00 a.m. Pacific). The domestic telephone number is (844) 578-9672, and the international number is (508) 637-5656. A live webcast of the call and a slide deck showcasing the products and details of the DFINE acquisition are available at www.merit.com.
ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy. Merit serves hospitals, acute care facilities and clinics worldwide, with a domestic and international sales force totaling approximately 200 individuals. Merit employs approximately 4,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; and Mannheim, Germany.
Statements contained in this release which are not purely historical, including, without limitation, statements regarding anticipated revenues, earnings or other financial items; Merit’s plans and objectives for future operations; proposed products or services; integration, development or commercialization of the DFINE operations and assumptions underlying any of the foregoing , are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015. Such risks and uncertainties include risks relating to Merit’s acquisition of DFINE; Merit’s efforts to integrate, manage and develop DFINE’s operations and products; expenses associated with the integration, management and development of those operations and products; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval of Merit’s products (including the DFINE products) and risks that such products may not be developed successfully or approved for commercial use; regulation of the medical device industry; Merit’s need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; restrictions on Merit’s liquidity or Merit’s ability to operate its business in compliance with its debt agreements; possible infringement of its technology (including the DFINE technology) or the assertion that such technology infringes the rights of other parties; changes in the prices or supply of commodity components; changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with suppliers, or failure of suppliers to perform; fluctuations in exchange rates; development of new products and technology that could render Merit’ products (including the DFINE products) obsolete; changes in key personnel; potential healthcare regulatory and policy changes; and other factors referred to in Merit’s Annual Report on Form 10-K for the year ended December 31, 2015 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.
Contact: Anne-Marie Wright, Vice President, Corporate Communications Phone: (801) 208-4167 e-mail: [email protected] Fax: (801) 253-1688