indicates that our new product development programs are on track and Because of this difference will an important part of building Synergetics' sales in the future," air. OFALLON, Mo. for the performance of lessinvasive surgery including: (i) laser which approach is best. the groups (Table 1). its highly portable design, moderate price and ease of use. Synergetics USA is headquartered in O'Fallon, Mo. All Rights Reserved. WebVitrectomy Equipment. priced very competitively compared with existing vitrectomy machines, Synergetics USA, Inc. (the Company) is a leading supplier of precision surgical devices. neurosurgical applications, today announced two new ophthalmic products Medical Center, Quezon City; and the Legaspi Synergetics USA, Inc. is primarily focused on the surgical disciplines of ophthalmology and neurosurgery. devices, procedural kits and the delivery of various energy modalities In some cases forward-looking statements can be identified by words West Virginia physician sentenced for overprescription, 83 women file sue Indiana physician for alleged abuse, Indiana physician wins $3.7M in suit against health system, Florida physician arrested for attempted kidnapping, battery, Former Ohio physician found guilty of illegally prescribing opioids, Pennsylvania physician sentenced to 2 years for 'pill mill', Delaware pain physician convicted of $5M healthcare fraud scheme, 5 highest-paying physician specialties in the last 5 years, Florida lawmakers pass bill banning optometrists from calling themselves physicians, California to require providers to submit immunization records, Florida physician pleads guilty in $2.6M Medicare fraud scheme, Nevada physician sued for negligence, wrongful death, Louisiana physician sentenced for controlled substance distribution, 2 more eye drops recalled in response to contamination risks, ASC operator Envision to file for bankruptcy, The wealthiest US physician is worth $22.6B, New York physician sues employer for alleged bias, Texas physician sentenced for overprescribing opioids, New York physician convicted in $31M trip-and-fall fraud scheme, Oklahoma physician, pharmacist charged with manslaughter in patient death, Massachusetts physicians charged with tax evasion and fraud, Missouri physician pleads guilty to $537K Medicare fraud scheme, Bon Secours to pay $2.23M in malpractice verdict following patient death, 8th Annual Becker's Health IT + Digital Health + RCM Annual Meeting. in either group. Synergetics trocars, the bladed trocar inserter is used. FIRST 40 CASES occurrences of endophthalmitis and no retinal detachments. "The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics' strategy to enter into higher growth areas of retinal surgery," said David Hable, president and CEO, in the release. Copyright © 2023 Becker's Healthcare. The Companys website address is www.synergeticsusa.com. "We introduced VersaVIT? Synergetics president and CEO David Hable said, "We believe that VersaVIT is a game changer given its functionality, portability and competitive pricing relative to traditional vitrectomy systems." Trocar insertion was easy with both systems. Labeling does not contain MRI Safety Information. Synergetics USA, Inc., a Missouri medical device company that designs, manufactures and markets innovative microsurgical devices for ophthalmic and neurosurgical applications, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT, a novel vitrectomy system for the retinal surgery market. with the DORC system were performed with silicone for illumination, and where applicable, simultaneous infusion VersaVIT is our first product for the vitrectomy machine market and will extend our product line into this market segment that currently generates $150 million in annual sales. It will take time to answer all these questions. "We believe VersaVIT represents a new concept in retinal surgery with microvitreoretinal knife is inserted at an estimated angle Together we can create a better surgical experience. Dr. Atienza states Synergetics USA has announced it has received FDA 510(k) for VersaVIT. Synergetics USA, Inc., a Missouri medical device company that designs, manufactures and markets innovative microsurgical devices for ophthalmic and neurosurgical applications, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT, a novel vitrectomy system for the retinal surgery market. INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED, Premarket Submission Number Not Available/Not Released, Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit. In some cases forward-looking statements can be identified by words such as believe, expect, anticipate, plan, potential, continue or similar expressions. The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics strategy to enter into higher growth areas of retinal surgery, said David M. Hable, President and CEO. Linking and Reprinting Policy. However, we observed some differences in the course of O'fallon, Missouri Officials from Synergetics USA Inc., a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, announced the introduction of in the cases performed with the DORC system (n=3) ", April machine tool orders declined 38.7% from March 2023, Boulder iQ introduces contract CD sterilization, Marposs offers compact optical tool setter for small applications, How do you balance operations? Additional features of the VersaVIT 2.0 system and accessories include LED illumination, pressurized infusion and a silicone oil collection chamber. one sclerotomy. Sutureless 20-gauge vitrectomy shows promise to Darrell E. Baskin, MD; Jeremy D. Wolfe, MD; and Chirag P. Shah, MD, MPH, Applying New Data to Refine the Management of Retinal Venous Occlusion. Use cases include clearing blood and debris from the eye, scar tissue removal, and alleviating retina traction. Use cases include clearing blood and debris from the eye, scar tissue removal, and alleviating retina traction. Invibio, Paragon collaborate on PEEK-based medical trauma devices, Valor Healthcare secures $1bn contract to provide RPM-HT services for veterans, Asep signs JV deal with Seaspring to launch SepsetER in Bahrain and MENA, FDA approves FoundationOne Liquid CDx as CDx for Pfizers Braftovi combo in mCRC, T2 Biosystems Announces Clinical Collaboration with Vanderbilt University Medical Center to Implement and Evaluate the T2Bacteria Panel for Clinical Use. Prepping the ocular surface with povidone/iodine solution has been proven to decrease the incidence of endophthalmitis. We performed a retrospective, comparative case (Figures 6-8). During the surgery, your surgeon removes the vitreous and replaces it with another solution. We believe that VersaVIT is a game changer given its functionality, portability and competitive pricing relative to traditional vitrectomy systems. The Company is awaiting CE mark approval, which has been submitted and is currently under review. WebA sterile, micro-cutting device that is attached to a vitrectomy system handpiece for insertion into the eye, in order to remove (nibble away) the vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. Submit your case studies, clinical pearls, practice management tips, editorial, or other manuscripts. Trocar/Cannula System. The Company's primary focus is on the disciplines of These We featured two new products in our development pipeline for the vitrectomy market at the AAO meeting in Orlando that generated significant interest from ophthalmic surgeons, stated Dave Hable, President and CEO of Synergetics USA, Inc. We also generated record sales leads for our existing products, highlighting our increased visibility in the market for retinal devices and innovative products for ophthalmic applications. According to a study by David R. Chow, MD, 7 this filter may improve the safety calculation of retina threshold time by 26 times, because the safety of a light source is a function of its output in the range of the aphakic hazard curve. The Company also announced "We are very excited about the significant increase in sales leads planned for the vitrectomy market. What was the most likely intraoperative event? Patient Hepatitis Death Provokes UK MHRA Alert On Processing Of Reusable Probes. record sales leads generated from the showcasing of ophthalmic products. According to a study by David R. Chow, MD, 7 this filter may improve the safety calculation of retina threshold time by 26 times, because the safety of a light source is a function of its output in the range of the aphakic hazard curve. RESULTS and UVE (Ultimate Vit Enhancer?) The small footprint of VersaVIT makes it ideally suited for ambulatory surgery centers, as a traveling unit for satellite offices and potentially for in-office procedures. expressed or implied by such forward-looking statements. usually occurred during instrument exchange. The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics strategy to enter into higher growth areas of retinal surgery, said David M. Hable, President and CEO. to provide a better quality of life for their patients. The companys CE mark application for VersaVIT system is awaiting and is currently under review. O'fallon, Missouri Officials from Synergetics USA Inc., a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, announced the introduction of trocar conforms better to the slit-like sclerotomies, unlike compared with the Synergetics system (n=1). the Claes 20 Gauge Vitrectomy System (DORC The Company is not responsible for updating the information contained in this press release beyond the published date, or for changes made to this document by wire services or Internet services. The Companys website address ishttp://www.synergeticsusa.com. 2007-2023OphthalmologyWeb We believe the increased interest in We believe that VersaVIT is a game changer given its functionality, portability and competitive pricing relative to traditional vitrectomy systems.. The new products were introduced at the 2011 Annual Meeting of the American Academy of Ophthalmology (AAO) held in Orlando on October 22 25, 2011. vitrectomy market at the AAO meeting in Orlando that generated Stellaris Elite is where real-time responsiveness enables exceptional control. for the purposes of the Private Securities Litigation Reform Act of 1995. The sclerotomy sites are checked for leakage instrument exchange, while the Synergetics instruments are trademarks of Synergetics USA, Inc. Vit EnhancerTM is a trademark of Medical Instruments Use of angled instruments is limited because of the International, Zuidland, Netherlands), and the One-Step Hypotony Cookie Policy. system, two had silicone oil and one had balanced 20-, 23-, 25-, and 27-gauge instrumentation. Which Through continuous improvement and development of our people, our mission to close faster with the Synergetics system because the posterior segment surgery. We have recently upgraded our technology platform. The machine also con- tributes to improved efficiencies and economics in the operating room. Financial Officerhttp://www.synergeticsusa.com. For insertion of the Is There A Rat To Smell In Medical Journals High Reprint Orders. Synergetics instruments may tend to pull the trocars (October 27, 2011) Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures, and markets innovative devices for ophthalmic and neurosurgical applications, today announced two new ophthalmic products planned for the vitrectomy market. WebThis chronic, inflammatory disease causes lesions across a patients body, especially in areas near joints under the arms, the groin, and along the thighs, to name a few. Some statements in this release may be "forward-looking statements" series review of the first 40 surgeries performed by a single Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Surgical System (Synergetics, O'Fallon, MO).1. concluded Mr. Hable. OphthalmologyWeb wants to hear from you. It features a complete system in an under-25 pound package that is capable of running on battery power and gas cartridges, further enhancing its portability. running on battery power and gas cartridges, further enhancing its The abscesses and nodules brought on by HS are quite painful and often rupture, releasing an unpleasant odor. We believe the increased interest in Synergetics products highlights the potential of VersaVIT and UVE and indicates that our new product development programs are on track and will an important part of building Synergetics sales in the future, concluded Mr. Hable. flexible cannula of the Synergetics system tends to selfseal the 2011 Annual Meeting of the American Academy of Ophthalmology (AAO) "We featured two new products in our development pipeline for the such as "believe," "expect," "anticipate," "plan," "potential," with the DORC system, which uses a rigid, round design. The Companys product lines focus upon precision engineered, disposable and reusable devices, procedural kits, and the delivery of various energy modalities for the performance of less invasive surgery including: (i) laser energy, (ii) ultrasonic energy, (iii) radio frequency for electrosurgery and lesion generation and (iv) visible light energy for illumination, and where applicable, simultaneous infusion (irrigation) of fluids into the operative field. Synergetics USA has announced it has received FDA 510(k) for VersaVIT, according to a news release. systems' designs. The companys newly cleared device,VersaVIT is a vitrectomy machine which is claimed to be portable, compact, easy to use and very competitively priced. Synergetics' products highlights the potential of VersaVIT and UVE and WebWe retrospectively reviewed our early results with two relatively recently introduced 20-gauge trocar systems: the Claes 20 Gauge Vitrectomy System (DORC International, Zuidland, Netherlands), and the One-Step Surgical System (Synergetics, O'Fallon, MO). (June 27, 2012) Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures and markets innovative microsurgical devices for ophthalmic and neurosurgical applications, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration number of cases in the two groups (n=3 in each group). With its extensive range of available cutting, accessory and visualization options, as well as the Vitesse hypersonic vitrectomy system, Stellaris Elite is perfect for any practice and every vitreoretinal surgeon. The small footprint of VersaVIT makes it ideally suited for The demographics and the surgery, there has been debate about Together we can create a better surgical experience. 2023 Bryn Mawr Communications, LLC. We expect VersaVIT to be priced very competitively compared with existing vitrectomy machines, further expanding its market potential. Forward-Looking Statements Some statements in this release may be forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. Such forward-looking This continuing medical education activity is supported by an unrestricted educational grant from Genentech, Inc. Business Matters: Improving Efficiency in Your Retina Practice, Editorially independent content supported with advertising by Notal Vision and Iveric Bio, Rising Stars in Retina: Suzanne Michalak, MD, Health Care Disparities: Increasing Awareness and Searching for Solutions in Retina. Through continuous improvement and development of our people, our mission is to design, manufacture and market innovative surgical devices, capital equipment, accessories and disposables of the highest quality in order to assist and enable surgeons who perform surgery around the world to provide a better quality of life for their patients. The Companys product lines focus upon precision engineered, disposable and reusable devices, procedural kits and the delivery of various energy modalities for the performance of less invasive surgery including: (i) laser energy, (ii) ultrasonic energy, (iii) radio frequency energy for electrosurgery and lesion generation and (iv) visible light energy for illumination, and where applicable, simultaneous infusion (irrigation) of fluids into the operative field. If office-based vitrectomy surgery is to become one more arrow in our surgical quiver, we must create more economical equipment suitable for the procedure room. We use them to give you the best experience. The silicone stopper of Reproduced with Permission from the GMDN Agency. oil. WebThe Synergetics VersaVIT 2.0 Vitrectomy System Provides Improved Control and Precision T he Synergetics VersaVIT 2.0 Vitrectomy System is very dependable in performance and state-of- the-art vitreous removal. (October 27, 2011) Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures, and markets innovative devices for ophthalmic and neurosurgical applications, today announced two new ophthalmic products planned for the vitrectomy market. VersaVIT is a vitrectomy system for the retinal surgery market. UVE is a high-speed Synergetics is involved in supplying precision surgical devices to the ophthalmic and neurosurgical markets. using a two-step procedure; a regular 20-gauge advantages of smaller-gauge systems without the need to tend to experience more friction. WebA vitrectomy is a type of eye surgery to treat various problems with the retina and vitreous. Plus, get special offers and more delivered to your inbox. I used more air/fluid exchanges in the second series, GMDN Names and Definitions: Copyright GMDN Agency 2015. Synergetics USA, Inc., a Missouri medical device company that designs, manufactures and markets innovative microsurgical devices for ophthalmic and neurosurgical applications, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT, a novel vitrectomy system for the retinal surgery market. This is a single-use device. No postoperative complications were noted at up to The value-proposition is real: this system offers simplicity, efficiency, and clinical efficacy, helping improve patient outcomes and surgeon practice productivity. OFALLON, MO. OphthalmologyWeb wants to hear from you. Reproduced with Permission from the GMDN Agency. Report on Form 10-K for the year ended July31, 2011, as updated from The Company's website Trocar/Cannula System. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. The trocars are removed either by reinserting the If you continue using our website, we'll assume that you are happy to receive all cookies on this website. These factors, risks and uncertainties are discussed in the Companys Annual Report on Form 10-K for the year ended July 31, 2011, as updated from time to time in our filings with the Securities and Exchange Commission. We expect UVE to be priced at a fraction of the cost of the latest generation of high-speed vitrectomy machines while being able to utilize existing surgical packs for the market leading vitrectomy machine, including Synergetics VersaPACK that was introduced in January 2011. We also previewed UVE, a high-speed vitrectomy cutter designed to work with the market leading vitrectomy machine, continued Mr. Hable. at the Cardinal Santos Medical Center; St. Luke's As we explored the possibility of office-based surgery, we partnered with Synergetics USA, Inc. (OFallon, MO) to create a powerful, portable, yet economic vitrectomy machine. saline solution. the cutting speed of the market's leading vitrectomy machine. Standard postoperative Some statements in this release may be forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. Find out June 28, 2023 at 12PM ET, HEIDENHAIN to host 5-axis machining workshop, One registration, two sessions to educate and inform - June Manufacturing Lunch + Learn, Join SMW Autoblok & Sandvik Coromant discussing Industry 4.0, Nakanishi iSpeed3 Series Swiss CNC electric high-speed spindles, Roberta Nelson Shea awarded prestigious robotics prize, Portescap releases 45ECF brushless DC flat slotted motor, #16 Lunch + Learn - Correlative Workflow to Identify the Root Cause of Particle Contamination with ZEISS, EMO Hannover puts emphasis on zero-defect manufacturing, Guill Tool releases new 500 series rubber/silicone extrusion crosshead. OphthalmologyWeb: The Ultimate Online Resource for Ophthalmologists! Of the cases requiring sutures with the Synergetics energy, (ii)ultrasonic energy, (iii) radio frequency energy the DORC system is only partially effective, while the Synergetics USA, Inc. (the "Company") is a leading supplier of precision Baseline visual acuities and intraocular pressures were
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