LONDON, May 28, 2020 /PRNewswire/ -- Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, is pleased to announce the market introduction and first commercial procedure of its Tula System – an in-office solution for placement of tympanostomy tubes (commonly known as ear tubes).
The Tula System gives ENT surgeons an option to place ear tubes in an awake child during an office visit without the need for general anaesthesia. The physician numbs the eardrum using a novel, child-friendly anaesthesia while the patient may sit up, play, and remain with their parent. A specialized tube delivery system allows the physician to place an ear tube in less than half a second, minimizing the amount of time the child needs to remain still. Most children return to normal activities immediately following the Tula procedure.1,2
The first procedure utilizing the Tula System since receiving FDA approval was successfully performed yesterday by Dr. Ritvik Mehta, MD, Otolaryngologist of California Head and Neck Specialists and investigator in the Tula Pivotal Clinical Study. "This personally hits home as my daughter had ear tube placement performed in the operating room," explained Dr. Mehta. "Even though I'm in a position to know exactly what to expect, it was a stressful event. I'm genuinely excited to be able to perform the same ear tube procedure, but in an office setting where children and families may avoid exposure to the risks and stresses of general anaesthesia – fasting, separation and after effects. This is a significant improvement to what we as ENTs can offer our patients."
Acute otitis media (commonly referred to as an ear infection) is one of the most prevalent childhood ailments in the United States, with an estimated annual cost of $2.8 billion.3 Every year in the United States alone, approximately 700,000 tympanostomy tube procedures are performed on children to address symptoms related to recurring ear infections and fluid in the middle ear.4
"I really like the Tula System because it gives parents the option of getting their child's ear tubes placed without a general anaesthetic," said Dr. Lawrence Lustig, Department Chair of Otolaryngology-Head & Neck Surgery Columbia University School of Medicine and New York Presbyterian Hospital and Principal Investigator of the Tula Pivotal Clinical Study. "From a parent's perspective, this is an enormous advantage – less time off work, and performed in an office setting. This technology represents a broader movement in our field towards patient-centered therapies."
"We are very excited to deliver a truly disruptive technology that elevates the standard of care by providing an alternative to general anaesthesia-based tympanostomy," said Brad Cannon, President, ENT and Sports Medicine for Smith+Nephew. "And, by better utilizing limited healthcare resources and freeing up precious OR space, it may potentially save the overall healthcare system hundreds of millions of dollars."
The Tula System is now available in select markets in the United States and will be available nationwide by the beginning of 2021.
Procedure typically lasts about 35 minutes. Tula Pivotal Study. Data on file
Lustig LR, Ingram A, Vidrine M, et. al. In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery. Laryngoscope 130; S1-S9, 2020.
Ahmed S, Shapiro NL, Bhattacharyya N. Incremental Health Care Utilization and Costs for Acute Otitis Media in Children. Laryngoscope 124(1); 301-305, 2014.
Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data from Hospitals and Ambulatory Surgery Centers: United States, 2010. National health statistics reports 102; 2-14, 2017.
Risk Statement The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anaesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include, but are not limited to, inadequate local anaesthesia, dizziness, and common tympanostomy procedure risks. For full prescribing information including contraindications, warnings and precautions, see the Tula IFU (IFU0007011) and TYMBION Drug Package Insert (IFU0007010) at www.tulatubes.com/IFU. Rx only.
About Smith+Nephew Smith+Nephew is a portfolio medical technology business that exists to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 17,500+ employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT.
Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.1 billion in 2019. Smith+Nephew is a constituent of the FTSE100 (LSE:SN,NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.
Forward-looking Statements This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.