The studies shown below are examples of the safety and benefits that Perclose ProGlide™ SMCS may provide patients requiring small or large sheaths in artieral or venous access procedures.
A study showing ambulation times, costs and patient satisfaction between the two methods of hemostasis approaches.
Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization.
International Journal of Cardiology: Heart and Vasculature, 2016
It is unclear whether early ambulation with Perclose ProGlide™ Suture-Mediated Closure System is safe or is associated with patient satisfaction and cost savings as compared with manual compression.
Evaluate the efficacy and cost-effectiveness of early ambulation (within 30 minutes) following femoral artery closure with the Perclose ProGlide™ SMCS in patients undergoing diagnostic cardiac catheterization compared with manual compression.
Prospective, single-center study of 170 patients equally split into two arms measuring patient ambulation (20 feet within 30 minutes), time to hemostasis, and time to discharge. Using a fully allocated cost model, a cost analysis of both Perclose ProGlide™ SMCS and manual compression was performed. Also, a multivariate analysis was used to determine predictors of patient satisfaction.
The primary endpoint was time-to-ambulation (TTA) following device closure.
| Perclose ProGlide™ SMCS (n = 85) |
Manual Compression (n = 85) |
P-value | |
|---|---|---|---|
| Time to hemostasis (mean) | 1.5 min | 20.4 min | <0.001 |
| Time to ambulation (mean) | 27.1 min | 248.0 min | <0.001 |
| Time to discharge (mean) | 59.6 min | 349.9 min | <0.001 |
| Procedural success | 100% (85/85) | 96% (82/85) | 0.12 |
| Overall complications | 3.5% (3/85) | 11.8% (10/85) | 0.08 |
Perclose ProGlide™ SMCS provided nearly $1,000 in cost savings per patient compared to manual compression.
| Perclose ProGlide™ SMCS (n = 85) |
Manual Compression (n = 85) |
|
|---|---|---|
| Total procedural cost (without hemostasis device) |
$564.5 ± 132.3 | $553.7 ± 121.0 |
| Hemostasis device cost1 | $278.2 ± 77.4 | $41.6 ± 22.4 |
| Post-procedural cath lab holding2 | $308.5 ± 78.8 | $1,190.8 ± 333.6 |
| Total adjusted nursing costs3 | $99.1 ± 41.1 | $389.5 |
| Hospital adjusted in-patient expenses4 | $0.0 | $2,052.6 ± 250.2 |
| Total cost | $1,250.3 ± 146.4 | $2,248.1 ± 910.2 |
| Incremental savings per patient | $983.6 |
Perclose ProGlide™ SMCS helps reduce severe levels of patient discomfort as compared to manual compression.
An overview of the Least Invasive Fast-Track EVAR (LIFE) Registry
Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry.
VIVA 2016
Demonstrate the clinical and cost benefits associated with the ultra-low profile (14F) Ovation‡ Abdominal Stent Graft platform under the least invasive conditions, including percutaneous access, no general anesthesia, no ICU admission, and next-day discharge.
Prospective, non-randomized, multi-center post-market study of 250 patients at 35 U.S. centers
Major adverse event within 30 days (10.4% target performance goal)
Perclose ProGlide™ SMCS had a high technical success rate with no device or procedure-related major adverse events.
| Perclose ProGlide™ SMCS (n = 250) |
 |
|
| Technical success | 97.6% | |
| Device-related MAE | 0% | |
| Procedure-related MAE | 0% | |
| Hours to ambulation (median) | 7.9 Hours | |
| Hospital stay (mean) | 1.2 days |
The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the hospital stay contributing to the majority of the amount.
| Standard EVAR1-2 | Fast-Track EVAR | Fast-Track Savings | |
|---|---|---|---|
| Anesthesia | General, 84% $500 |
Local, 100% $300 |
$200 |
| Access | Cutdown3 $300 |
Bilateral PEVAR $1,200 |
($900) |
| ICU | 1.4 Days, 51% $15,300 |
0 Days, 0% $0 |
$15,300 |
| Non-ICU | 2.3 Days $12,900 |
1.2 Days $6,700 |
$6,200 |
| 30-Day Reintervention | $29,400, 1.1% $300 |
0% $0 |
$300 |
| Total | $29,300 | $8,200 | $21,100 |
Perclose ProGlide™ SMCS had a high technical success rate with no device- or procedure-related major adverse events.
The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the longer hospital stay contributing to the majority of the difference.
MAT-2002632 v2.0
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