Astura Medical received 510(k) clearance for its Sirion Lateral Lumbar Interbody Fusion (LLIF) System. From initial access with the retractor to the interbody and plating options, the Sirion LLIF System offers intraoperative flexibility and efficiency with a procedural solution for lateral surgery based on surgeon preference. Developed internally to ensure intricate design details and quality benchmarks, the Sirion retractor allows for customized access with a 2- or 3-blade configuration, each blade having infinite, independent distraction and toeing capability. An optional anterior blade is available in multiple widths, and various shims and bone pins allow surgeons to tailor retractor access and rigidity to each patient’s needs.
Cagent Vascular received FDA 510(k) clearance of its Serranator PTA Serration balloon catheter for treating below-the-knee (BTK) lesions. The Serranator angioplasty balloon device is FDA cleared and CE marked, embedding serration technology into a semi-compliant balloon for treating peripheral artery disease (PAD). It’s designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
Tissue Differentiation Intelligence LLC (TDi) received 510(k) clearance for the SonoVision ultrasound platform designed for intraoperative access to the spine. Applying layers of image-processing algorithms to ultrasound images collected intraoperatively allows SonoVision to visually differentiate nerve, muscle, bone, and vessels in real time. FDA clearance will allow ultrasound to be used in imaging for spine surgery.
Work from home: Outside of manufacturing it is not only more possible than most companies allowed themselves to consider, it’s actually more productive in many cases and better for the environment. This nice green initiative costs a company almost nothing and may save some money. For the employees, work/life balance can improve.
Telemedicine: This overnight transition is 20 years in the making. It had been held back in most states because of reimbursement issues. Now that patients and practitioners are experiencing the benefits of telemedicine, it will be difficult to take away. This is good as telemedicine will result in more clinical productivity (seeing more patients) which will ultimately lead to more of our products being used. We should all be encouraging our local Congress people to tell Centers for Medicare & Medicaid Services (CMS) to keep the telemedicine reimbursement allowed under the COVID emergency. They should continue to expand it.
Digital health: A positive trend during the past decade, digital health needed a good crisis to get it over the hump of implementation inertia. We’re now seeing examples of higher growth in digital health solutions due to necessity. Most solutions will ultimately eliminate costs from our overly bureaucratic processes within healthcare.
Innovation: As industry veterans, it’s been exciting for us to see (1) the pace of innovation created by the talented and creative people in this industry and (2) the extraordinary efforts by the U.S. Food and Drug Administration (FDA) to allow use of innovative products to meet the pandemic’s needs. This industry/regulatory collaboration will hopefully bring benefits for years to come.
Of course, there are the very sad and unfortunate circumstances of lost lives during this crisis. We don’t take those lightly. What we can do is continue to adjust our attitude to consider what is possible for ourselves and for our industry.
We believe that COVID has proven our medtech industry is more innovative than ever. It has also shown us that we can create strong relationships with other industries (medtech and automotive for example), and that our talented people are more committed each day to creating a better future for all of our health issues.
Bottom Line: Even for those sidelined due to elective procedures (which we don’t believe will happen again – but that’s another article topic), we believe collectively that the medtech industry has proven itself more essential than ever. We remain proud to be alongside each and every one of you striving every day to make our lives better and healthier!
MetalPro Resources is Solar Manufacturing’s sales representative for Ohio, Indiana, and Kentucky. Jim Senne, Steve Maus, and Bill Andreski bring more than 100 years of combined heat-treating knowledge and experience. MetalPro Resources has offices near Cincinnati, Indianapolis, and Cleveland.
“We have relationships with the people of Solar going back decades, and the time was finally right for us to join forces,” Maus says. “Our region is rich in vacuum furnace applications and opportunities and we’re moving forward with the best possible partner in Solar Manufacturing.”
Solar Manufacturing also produced and installed a vacuum gas- nitriding furnace at its sister company Solar Atmospheres to handle increased demand for high-value gas nitriding. The front-loading furnace incorporates the latest nitriding and recipe system and all hot zone components are made completely of graphitic materials inert to the anhydrous ammonia used during the nitriding process.
In addition to a forced gas cooling system, the furnace also incorporates Solar Manufacturing’s convection heating system, reducing cycle time up to 50%.
Top 10 Global Medical Device Companies
Departments - Medical Infographic
Medical device manufacturing’s worldwide revenue exceeds $407 billion and projections are for continued, strong growth fueled by an aging population and response to COVID-19.
3D printed NP test swabs; personal protective equipment
In partnership with Formlabs, USF Health, Tampa General Hospital, and Norwell Health, ROE Laboratories has been granted a production license for 3D-printed nasopharyngeal (NP) test swabs. The current product capacity is more than 21,000 test swabs per day. The swabs are being printed from biocompatible, autoclavable, and FDA cleared surgical guide resin.
A clinical trial using EnvisionTEC 3D-printed nasopharyngeal (NP) swabs for COVID-19 testing will help address the shortage of the test devices. One advantage of the EnvisionTEC NP swab is it performed the same, mechanically, after being sterilized by steam at 270°F at 27Pa in an autoclave. E-Guide Soft, a biomedically safe 3D printing material from EnvisionTEC, and EnvisionTEC’s swab design have both passed all required tests.
EnvisionTEC worked with Beth Israel Deaconess Medical Center (BIDMC) to develop a swab design and material to be printed on its Envision One cDLM 3D printer, which can produce up to 2,400 swabs in 24 hours.
EnvisionTEC, and a growing number of their Envision One cDLM customers who have also registered with the FDA, have the mass production capabilities to produce up to one million swabs per day.