MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Medtronic lands Japanese approval for CoreValve trial | Regulatory Roundup

Medtronic lands Japanese approval for CoreValve trial | Regulatory Roundup

By

CoreValve

Medtronic (NYSE:MDT) implanted its CoreValve transcatheter aortic valve implantation system into the first patient in a Japanese clinical trial of the device’s safety and effectiveness.

The CoreValve system is a minimally invasive treatment option for patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.

"With the number of aortic valve stenosis patients steadily rising as the Japanese population ages, we consider this an important step towards the introduction of a new therapeutic option to the health care system," lead surgeon and professor in the cardiovascular surgery department at Osaka University Hospital Dr. Yoshiki Sawa said in prepared remarks.

The device, currently limited to investigational use in the U.S., won approval from Korean regulators earlier this month and expanded CE Mark approval in the European Union in August, but is still years away from the U.S. market.

CoreValve "looks like a 2014 product for the U.S.," Medtronic executive VP and cardiac and vascular group president Michael Coyle said at an annual shareholders meeting in August.

That puts CoreValve two years behind competitor Edwards Lifesciences Corp.’s (NYSE:EW) Sapien valve, which got a positive FDA panel vote in July.

Edwards has staked its flag on an October 2011 release, sinking about $40 million into a launch that Edwards’ chairman & CEO Michael Mussallem said will allow the company to compete in 200 to 400 medical centers in the U.S. 

Edwards and Medtronic have gone back and forth over valve patent disputes, most recently resulting in a $74 million patent infringement loss for Medtronic. A federal judge denied Edwards’ move to bar U.S. manufacturing and sales of CoreValve, which Medtronic acquired in in its $700 million buyout of CoreValve Inc. in 2009.

Medtronic also announced a novel approach to minimally invasive spinal fusion allowing surgeons to access the spine in the lower back, according to a press release.

Regulatory Roundup

  • Claret Medical lands CE Mark
    Claret Medical Inc. announced today that its Montage System has received CE Mark approval as the world’s first complete system of filtration to protect both carotid arteries simultaneously. 
    Read more

  • Spinal implant company touts FDA clearance
    LDR, a privately held spinal implants company, announced that it received 510(k) clearance to market the ROI-A Oblique ALIF cage.
    Read more

  • Imaging3 completes second milestone toward FDA clearance
    "I am able to report to you that our October 17, 2011 meeting with the FDA went as anticipated and we have successfully completed the second milestone of our three phase submission process," Imaging3 (OTCBB: IMGG) chairman & CEO Dean James said in prepared remarks.
    Read more

  • ClearCount lands CE mark for SmartSponge
    ClearCount Medical Solutions announced received approval to affix the CE mark to its SmartSponge and SmartWand-DTX products. The SmartSponge product line is the first and only RFID-based surgical safety and efficiency technology bearing a CE mark, according to a press release.
    Read more

  • Brainsway wins IDE approval for bipolar disorder trial
    Brainsway (TASE:BRIN) received an Investigational Device Exemption approval from the FDA, allowing it to begin a multicenter clinical trial to evaluate the efficacy of its Deep TMS device in the treatment of subjects with bipolar disorder.
    Read more

    • In case you missed it

    RSS From Medical Design & Outsourcing

    • Smith+Nephew expands reach of its Cori handheld robotic system
      A year after Smith+Nephew (NYSE:SNN) launched its Cori handheld robotic system in the U.S.,  the ortho surgery system has launched globally. The British medtech giant has expanded Cori’s reach to Europe, Australia and New Zealand, India, and Canada (just announced today). The company yesterday said the system was now available for use in the U.K.’s National Health… […]
    • Elizabeth Holmes reportedly expresses remorse in criminal fraud trial
      Elizabeth Holmes reportedly revealed some regret over her handling of business as the ex-Theranos CEO took the stand again in a criminal fraud trial. Taking the stand yesterday for the third day of testimony in federal court in San Jose, California, Holmes was said to have shown remorse while still shifting some of the blame… […]
    • Supply chain, manufacturing issues slow Medtronic’s Hugo launch, ramp-up expected next fiscal year
      Medtronic (NYSE:MDT) Chair & CEO Geoff Martha confirmed that the launch of the Hugo surgical robot platform is off-schedule. Hugo received CE mark approval last month. The company is gearing up to conduct its FDA investigational device exemption (IDE) clinical trials in the U.S., with more on its stateside efforts still to come, Medtronic’s surgical robotics… […]
    • Minnetronix Medical honored in Minnesota for its MindsEye Expandable Port
      Minnetronix Medical (St. Paul, Minn.) received an award from the Minnesota Technology Association that highlights its MindsEye Expandable Port for minimally invasive deep brain access. The company won the association’s TEKNE award for best medical technology and devices. “Given Minnesota is a global epicenter for the medical device industry, this award is quite meaningful to Minnetronix… […]
    • BD expands biosciences business with reagent innovation center in San Diego
      A life sciences real estate developer announced today that BD (NYSE:BDX) selected its property as a new facility for its biosciences business. Through a joint venture with Tishman Speyer and Bellco Capital, Breakthrough Properties confirmed that BD chose its Torrey View by Breakthrough property for an expanded San Diego reagent innovation center within its biosciences… […]
    • The best places to work for medtech sales reps in 2022
      Teleflex (NYSE:TFX), ConMed (NSDQ:CNMD) and Medtronic (NYSE:MDT) topped the list of best places to work in medtech sales in 2022, according to a MedReps.com survey of medical sales representatives. The 11th annual MedReps survey polled over 2,300 MedReps professionals to determine which medtech sales companies are most sought-after in the industry. Overall, pay and leadership were the most… […]
    • How medtech fared in the first waves of the pandemic
      Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data. Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying… […]
    • FreeStyle Libre 3, other Abbott products recognized at CES Innovation Awards
      Abbott (NYSE:ABT) was honored for a handful of its offerings at the Consumer Electronics Show (CES) 2022 Innovation Awards. The company’s FreeStyle Libre 3 continuous glucose monitoring (CGM) system ranked among the top 15 products in the CES Best of Innovation category. The next-generation CGM system features the world’s smallest, thinnest glucose sensor that can… […]
    • Evonik launches new Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices
      Evonik has launched the second generation of Resomer PrintPowder polymers for 3D printing of personalized, implantable medical devices. Essen, Germany-based Evokik said the powders have a broader range of customizable mechanical properties and degradation rates, allowing their use for more complex and tailored medical devices including orthopedic, dental, or soft tissue applications. “These new powders… […]
    • Tungsten cable for surgical robotics: Challenges solved introduce new unsolved challenges
      Tungsten cable is the perfect strength, flexibility, and diameter for surgical robots. Connor Chiuchiolo and Scott Dailey, Carl Stahl Sava Industries When manufacturing tungsten mechanical cable for surgical robotics, the tungsten itself presents enormous mechanical upside, including extraordinary tensile strength captured within astonishingly small diameters. What’s more, tungsten stranded into ultrafine mechanical cable possesses a remarkable… […]
    • FDA says Philips knew about toxic foam for years before massive recall
      The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam… […]

    Leave a Reply