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
Acute otitis media (commonly referred to as an ear infection) is one of the most prevalent childhood ailments in
'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.
'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
The Tula System is now available in select markets in
Contact:
Tel: +1 978-749-1440
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 anesthesia 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 anesthesia, dizziness, and common tympanostomy procedure risks.
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
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
(C) 2020 Electronic News Publishing, source