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A REVOLUTIONARY DEVICE DESIGNED TO CORRECT ERGONOMIC LIMITATIONS OF LEFT RADIAL ACESS PROCEDURES

StandTall is a Class I, external specialty support-sheath that readily facilitates left radial artery access (LRA) approach without the loss of operator hand dominance. StandTall simultaneously improves physician ergonomics with measurable advantages and minimal disruption in workflow. Primary use for StandTall is for left radial artery access (LRA) for Percutaneous Coronary Intervention (PCI).

StandTall features:

  •  Single-use, 8.3 Fr, 25 cm coiled, extension sheath
  •  Hydrophilic inner lining
  • Adhesive multi-position clasp allows secure positioning:  0 – 1800
  • Universal Adapter: compatible with majority of introducer sheath 5-8 FR Terumo, Boston Scientific and Medtronic vascular access sheaths and 8-FR Cook Sheath

The universal adaptor securely attaches the StandTall external specialty support-sheaths to the vascular access sheath. The adhesive clasp is then positioned to secure StandTall in the optimal place and adhered to the patient or drape. StandTall is then shaped into its desired position and secured onto the adhesive clasp. StandTall redirects and stabilizes workflow back to the physician, staff and standard room set up.  (End Column 1 copy, hopefully

Primary Use for StandTall is for Left Radial Artery Access (LRA) for Percutaneous Coronary Intervention (PCI).

The current debate regarding best primary access site for PCI: 

The many advantages of trans-radial percutaneous coronary intervention (PCI) continue to expand. Hospitals are capitalizing on this trend by integrating radial access into their PCI programs, given the significant cost savings and patient preferences6. While LRA approach offers significant clinical advantages, RRA has seemingly become the primary wrist access site of choice in recent years. Workflow and patient positioning advantages as well as maintenance of physician right hand dominance likely explains this preference in spite of several limitations of a right wrist approach.

Additional procedures where StandTall will benefit:

  • Antegrade arterial puncture for arterial intervention
  • Arterial-venous fistula intervention
  • Acute Stroke and emergent CNS reperfusion.
  • Pedal access for limb salvage and chronic limb ischemia
  • Morbidly obese patient management.

Radux Devices believes the primary aversion to LRA conversion is related to the increased operator stress and higher early radiation exposure rates from leaning over the patient while working from the right side. Alternatively, the physician and staff can reposition room set up to the left side of the patient, requiring use of operators’ non-dominant hand for fine motor activity, a suboptimal setup. Stand Tall addresses and overcomes these concerns.

Using StandTall as part of the endovascular protocol will provide the physician with a more comfortable and stable workflow environment while reducing MSK stress and fatigue when conducting fluoroscopic procedures.


Making A difference

Standard RRA Access for PCI with standard Right sided access

Advantages: (RRA vs. LRA)

  • Similar Set up to right groin access
  • Right handoperator dominance preserved

Disadvantages: (RRA vs. LRA)

  • Use patient’s dominant hand
  • 6 X Higher failure rate*
  • Longer, more tortuous route
  • Longer learning curve**
  • Increased stroke rate***
  • Worse survival in shock and STEMI***

*. Fernandez-Portales J et al. Right Versus Left Radial Artery Approach for coronary angiography: Differences Observed and the Learning Curve. Rev Esp Cardiol. 2006;59(10):1071-4).

** Schiahbasi A et al. Transradial approach (left vs. right) and procedural times during percutaneous coronary procedures: TALENT study. Am Heart J. 2011;161:172-179.

***Lardizabal J et al. Right Versus Left Radial Artery Access. May/June 2012. Cardiac Interventions Today; 53-57

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Standard Left Radial Artery (LRA) Approach from a Left Sided Approach

Advantages: 

  • Same as LRA access form standard approach

Disadvantages: (RRA vs. LRA)

  • Opposite room set up. Have to place equipment in opposite position.
  • Right hand dominance lost for fine motor skills
 

LRA Access from Standard Right Sided Approach

Advantages: (LRA vs. RRA)

  • Higher success rates
  • Use Patient’s non dominant hand
  • Easier pathway to heart
  • Maintain right side table set up.
  • Anatomy similar to Right groin approach
  • Right hand dominance maintained

Disadvantages: 

  • Increased physical stress*****
  • Higher potential radiation dose
  • Limited device control/table management

***Lardizabal J et al. Right Versus Left Radial Artery Access. May/June 2012. Cardiac Interventions Today; 53-57 . 

***** Kado H Et al. Operator Radiation Exposure and Physical Discomfort During a Right Versus Left Radial Approach for Coronary Interventions: A Randomized Evaluation. JACC,Vol 7;7: July 2014:

LRA Access from StandardRight Sided Approach with StandTall

Advantages: 

  • All the ergonomic benefits RRA
  • All the clinical benefits LRA
  • Patient hand preference
  • 30% Decreased MSK stress****
  • 70% Decreased radiation dose****
  • 23% Improved sterility****

Disadvantages: 

  • Requires longer catheter and guide system (125 cm system). Limited availability.

****Proof of Concept Study: “StandTall” Sheath to Reduce Occupational Health Hazards for Interventional Radiologists. Sara Myers, PhD, Study Director / Principal Investigator, Department of Biomechanics, University of Nebraska at Omaha. John Lof, MS, Research Manager Joint Cardiovascular Research Laboratory. University of Nebraska Medical Center. Frank Rutar, MS, Director, Radiation Safety University of Nebraska Medical Center. Gregory Gordon, MD, Assoc. Prof. Medicine. University of Nebraska Medical Center. Final POC Report delivered to UNMC 04/05/16. UNMC IRB Protocol Number:  402-14-FB. UNMC IACUC Protocol Number: 14-039


WHAT INTERVENTIONALISTS HAVE TO SAY ABOUT current Occaptional Health  risks in the angiography suite

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72%  Express significant concern about radiation exposure and     occupational health issues.

77%  Believe inadequate resources are devoted to radiation protection.

77%   Want to try new products in the IR suite.

94%   Link ergonomic constraints with radiation exposure and occupational stress.

how standtall addresses risk in the angiography suite

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Proof of concept study demonstrated significant ergonomic health improvements in endovascular specialists when using StandTall versus standard vascular access in an ergonomically challenging approach; antegrade femoral access.

70% reduction in operator hand radiation exposure

30% less operator fatigue

23% improved sterility

Easy sheath repositioning

Improved access site stability

Enhanced patient safety