MEDICAL DEVICE INNOVATION - Medical Device Daily

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74 LenSar developing laser technology for cataracts By AMANDA PEDERSEN Medical Device Daily Staff Writer LenSar (New York), a startup company, says it is developing a new laser therapy that could potentially remove cataracts from people’s eyes more efficiently and with greater precision than the current technology used to treat cataracts. The company presented the technology at the recent American Academy of Ophthalmology (San Francisco) meeting. Joseph Dello Russo, MD, a New York ophthalmologist who was among the first doctors to perform laser eye surgery, told Medical Device Daily that he has watched LenSar’s technology develop from a concept in 2004 to an actual laser, which the company began testing on patients in Mexico about a year and a half ago. More recently, the company began testing the laser on patients in the Philippines, he said. Russo has been affiliated with LenSar since its inception and up until about six months ago was on the company’s board. LenSar plans to continue testing human patients outside the U.S. until it has collected enough data to support that the technology actually works, Russo said. The company said it plans to start treating patients in the U.S. if the FDA will consider the technology to be safe an effective, based on the data. Cataracts are currently treated with a device known as a Phacoemulsifier, which uses ultrasound waves to break up the contents of the cataract and, according to LenSar, was nicknamed in the mid-seventies a “laser.” “People think of it as a laser, which it’s not,” Russo said. While the current technology is generally considered very safe, he said that results largely depend on the skill of the surgeon doing the procedure. LenSar believes that its laser will make cataract surgery easier to perform. Although the new device will cost more than the existing technology, LenSar says the speed of surgery may compensate for that by allowing more procedures to be performed in less time. Russo explained that the new laser technology has the potential to allow for the use of premium implants, which set up bifocal vision as well as provide a better way to treat astigmatism. Such implants, Russo said, work best if they are implanted exactly in the center of the eye, which will depend upon the perfection of the capsulotomy – the incision into the crystalline lens of the eye to remove cataracts – which is currently done by hand. “Most of us can do that pretty good, but there’s nothing like a laser that can do it precise[ly],” he said. Improved precision would also make the procedure safer, Russo said. “It’s taking the surgeon out somewhat MEDICAL DEVICE INNOVATION 2010 and making the laser do the work so it can be consistent all the time.” But only time – and more clinical testing – will tell if LenSar’s new laser technology will work. So far though, Russo says the results look promising. According to LenSar, the laser has been used in about 100 operations outside the U.S. The company was formed by LenSar’s CEO, Randy Frey, PhD, a scientist best known for the LASIK laser he developed, according to the company. LenSar acknowledged that it is in a head-to-head competition to be the first to commercialize the laser technology. However, Frey claims that he holds important patent applications, which allow the company to focus on R&D and pay less attention to competitors. He believes that LenSar’s patents will prevail and will have a legal claim on any such devices, regardless of their maker. Russo told MDD that he suspects that LenSar’s strongest competitor is a company called LenSx Lasers (Aliso Viejo, California). “Either LenSx or LenSar is going to be first,” he said, adding, “I’m not sure it’s important to be first or not.” According to LenSar, the real financial benefit for the company is not in the sale of the laser but in the “royaltylike” fee that is paid to the company each time the laser is used. (This story originally appeared in the Nov. 6, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Tru-Flo a novel approach for urinary catheter market By OMAR FORD Medical Device Daily Staff Writer Gordon Atkinson survived prostate surgery, but his most frustrating hurdle was having to use a catheter and bag following the procedure. The bag was difficult to conceal and was awkward when wearing shorts (he lived in Florida at the time) and engaging in leisure activities. “He was incredibly uncomfortable with the catheter,” Jeff Hale, of Link-It Medical (Hickory, North Carolina) told Medical Device Daily. “He couldn’t sleep at night or wear shorts. The catheter bag would slide down and it would just be awkward.” “I love to fish and sail, but the catheter and bag made it difficult for me to feel comfortable doing those things,” Atkinson said. I had all this tubing hanging on my leg, and I had to be careful not to snag it on anything. I definitely couldn’t wear shorts. If the tubing disconnects, which can easily happen, urine runs down your leg and soils your pants. I knew there had to be a better way.” With a background in fluid dynamics, Atkinson began tinkering away to make the device easier to use. He then teamed up with his doctor Mutch Yadven MD, to patent and make improvements to the concept. “When I showed it to Mitch, he said, ‘Do you know what you’ve done’” Atkinson said. “I think we both knew this valve could have life-changing potential.” The duo then teamed up with Hale’s company Link-It Medical and selected neophyte med-tech company ProtekMed (Hickory, North Carolina) to manufacture the device, which has been named the Tru-Flo urinary catheter valve. The company reported launching the device. It’s a Class I device and it’s considered a urinary accessory, so there is no need for a 510(k) or PMA according to the company. “What this valve does is, it allows the patient to have control over the drainage of urine,” Hale told MDD. “This is the first of its kind in the U.S. market. Interestingly enough there have been quite a few valves in Europe that have attempted to accomplish what we’re doing with Tru-Flo. But [ProtekMed] is looking at European market which is much more mature, but our primary focus is in the U.S.” The device itself is being touted as a huge game changer in the quality of life for catheter patients. Designed to be used in place of a bag, the valve connects to the end of the catheter tube and slides open and closed easily with one hand. With a secure, leak-free seal, a Tru-flo-equipped catheter can be drained directly into a commode at the convenience of the patient. The valve universally adapts to all Foley and Supra-pubic catheter systems. 75 By eliminating the bag and utilizing shorter catheter tubing, the entire catheter system is easily concealed thanks to Tru-flo - helping to restore patient comfort and dignity. And with no recessed or undercut external surfaces that can harbor bacteria, the Tru-flo valve has important design features for infection prevention. The company said that for patients utilizing the valve, the device should be opened every three-to-four hours initially. Some patients may have the urge to void and should open the valve as this occurs. The valve can be used safely overnight, or a bedside drainage bag may be attached before bed, reducing nocturia, and the valve replaced in the morning. Patient indications for use of the Tru-flo valve include the following: • Conditions of chronic urinary retention; • Conditions of acute urinary retention; • Other medical conditions requiring in-dwelling catheters. Contraindications include a high-pressure neurogenic bladder, a history of autonomic dysreflexia, a febrile UTI, and situations following any procedure or trauma where there is a possibility for urinary extravasation and urinary drainage is needed for optimal tissue repair, such as TURBT, bladder repair or trauma, or radical prostatectomy. Relative contraindications are gross hematuria with clot. “There has been a lot of interest with this device,” Hale told MDD. “We’ve got orders for [Tru-Flo] that have been booked and we look to have our first sales of the device [in the near future].” (This story originally appeared in the Oct. 28, 2009 edition of Medical Device Daily.) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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