A NEW MEDICAL DEVICE TO PREVENT AMPUTATIONS
The ConnREAP™ – Retrograde Entry Antegrade Placement—a simple, revolutionary medical device enabling a physician—for the first time—to direct a catheter from the groin straight down the leg to ease crossing of severe stenosis, chronic total occlusions, and to treat critical limb ischemia. ConnREAP™ is a method and a device to simplify entry into the leg arteries for crossing of severe stenosis and total occlusions in the femoral, popliteal; in particular, the small below-knee arteries through a femoral ante grade (straight-line) approach. In this technique, the surgeon directs a needle into the common femoral artery in the traditional retrograde direction, the familiar and common approach. In a simple next step a sheath is redirected ante grade towards the foot.
The device will be offered worldwide as a 5-piece disposable kit, enabling physicians to gain optimal access to the leg arteries and facilitate the best use of catheter and balloon equipment to restore blood flow and prevent amputations. According to independent studies, this device will substantially increase the rate of limb salvage. Tens of thousands of limbs could be saved per year in the USA alone.
Animated video of the procedure
A Growing Problem with Amputations:
In the USA, we experience at least 180,000 amputations per year; the success rate although high, results in a more than 60% mortality rate within one year after surgery. Technical challenges have severely limited surgeons’ ability to treat arterial blockages in the lower leg. Loss of guidewire torque and control is a critical problem. Traditional passage of long tubing systems “up-and-over” through the tortuous abdominal and pelvic arteries and across multiple steep angles in both directions has produced uncertain outcomes because of poor catheter tip control over those distances. The potential for harm is increased. As a result, fewer below-knee arterial reconstructive procedures are done than could be accomplished if reaching these arteries were simpler and safer. Based upon reported utilization data from Medicare Part B and proprietary all payer databases, the estimated number of lower extremity endovascular interventions in the US surpassed 450,000 from 2014, having grown from 360,000 cases (1) The ConnREAP™ could dramatically reduce amputations and save lives.
- An elegant ante grade approach straight down the leg from the groin.
- Protected by 4 US patents with no initial prior art found.
- Proof of concept completed in humans and an independent product evaluation.
- Product ready for final design and packaging within estimated 12-16 months to market launch
- No FDA approval required. A Trocar Procedure, covered by Medicare and Health Insurance
- Our surgical cases have demonstrated dramatic results that allow treatment saving limbs from amputation.
(1) Cleveland Clinic Innovations Product Evaluation, December 2016 USPTO
Warning: Graphic Video
The following is an actual video of the procedure. It is exceptionally graphic and may be disturbing. Discretion is advised.
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