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Monday, March 15, 2010

Rex Medical Cleaner Rotational Thrombectomy System Wins US Green Light

Filed under: Vascular Surgery

Rex Medical of Conshohocken, Pennsylvania won regulatory approval from the FDA to sell its Cleaner Rotational Thrombectomy System. The atherectomy system is based around a battery powered Cleaner device that rotates a tip at 4,000 RPM for drilling through arterial plaque.

  • 6Fr ergonomically designed, hand-held, battery operated drive unit
  • 6Fr introducer sheath compatibility
  • Atraumatic, effective wall contact and thrombus maceration with particulate aspiration through an introducer sheath
  • Superior trackability and steerability through tortuosity
  • Decreased procedural time and cost
  • Single use, disposable

    • Cleaner Device Specifications:

    Wire:

  • 0.035 inch diameter

  • Radiopaque tip

    • Catheter:

  • 6Fr shaft outer diameter

  • 65cm & 135cm length

    • Drive Unit:

  • Battery operated

  • 4,000 rpm

    • Press release: Rex Medical Cleaner™ Rotational Thrombectomy System Receives 510(k) Clearance ...

    Product page: Cleaner ...

    Flashbacks: Diamond Tipped 200,000 RPM Artery Drill ; Pathway Medical's Peripheral Plaque Drill Gets 510(k) Classification

    email this article to a friend      print this!           comments and peer reviews (1)     




    replies: 1 comments
    Open comments are not moderated, although abusive and vulgar remarks may be deleted. Opinions expressed do not necessarily reflect the views of Medgadget.com. Please consult our disclaimer.

    4,000 RPM? .035 inch diameter? Ouch! It makes me wonder what type of clinical testing is actually conducted before the FDA grants approval for these high-tech devices. The medical supply industry has sure grown. One for wheelchairs, catheters, and other medical supplies SportAid.com; now, entering into an age of Rotational Thrombectomy Systems and robots for out-patient care.


    Posted by: Steve
    on May 10, 2010 05:16 PM GMT

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