Benefits

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Svelte technologies reduce the cost of stenting – extracting steps, time and materials used – without compromise to patient care.

Reducing cost is at the forefront of healthcare today. Institutions and payers nationwide are increasingly scrutinizing the cost of products and techniques employed for percutaneous coronary intervention (PCI).

And for good reason.

With stenting long established as the standard of care for PCI, stent technologies and long-term clinical results have converged. DES are highly refined, providing outstanding performance during cases and excellent safety and efficacy outcomes.

However focus on outcomes alone is no longer enough.  Achieving optimal outcomes AND lowering the costs of care define success in the modern healthcare environment. Doing so requires challenging convention and taking a fresh approach to DES new product development.

Svelte technologies were developed specifically to address unmet needs in coronary stenting today: facilitate transradial intervention (TRI) and direct stenting while extracting steps, time and cost from stenting procedures without compromise to patient care.

By combining a guide wire, balloon and stent into a single ‘all-in-one’ system, low-profile Svelte technologies facilitate TRI, streamline stenting procedures and achieve efficiencies unlike any other DES.

Challenge Convention, Lower the Cost of PCI

The cost of PCI, though low compared with its surgical counterpart, is significant. Work to lower the costs of materials, personnel and overhead is always ongoing, though doing so is increasingly difficult as economies of scale are reached with conventional approaches to PCI. Creating ‘value’, i.e. the ability to improve healthcare outcomes (clinical, financial, etc.) per dollar spent, defines success today.

Challenging convention to redefine the approach to PCI through the use of more efficient techniques and cost-saving technologies creates much-needed value. Transradial and direct stenting techniques alone lower the costs of care compared with conventional stenting via transfemoral approach while imparting important benefits, including:

  • Reductions in radiation exposure, procedure steps and time1,2,3
  • Greater patient comfort, quicker time to ambulation and hospital discharge4
  • Cost savings in excess of $800 per patient treated4,5

Bleeding driven by vascular access complications is also observed more frequently with tranfemoral PCI, significantly increasing morbidity, mortality and readmissions following PCI.  Bleeding is also a leading healthcare cost overrun.  Avoidable readmissions are a major financial problem for the nation’s healthcare system; a single return trip to the hospital more than doubles the cost of care for Medicare patients undergoing PCI and receiving a DES, increasing costs from approximately $15,000 per episode of care to $31,000 with a single readmission6.

TRI and direct stenting enable shorter procedure times with fewer bleeding complications compared with conventional stenting, benefitting patients and directly leading to healthcare cost savings.

Reduce Overutilization, Inefficient Use of Resources

By combining a guide wire, balloon and drug-eluting stent into a single ‘all-in-one’ system, Svelte technologies streamline stenting procedures and achieve efficiencies unlike any other DES.

Physician-initiated studies demonstrate significant reductions in material use – fewer guide wires, PTCA balloons and even guiding catheters – compared with conventional DES.  Reducing product utilization per procedure lowers procedural cost, freeing up capital for value-add technologies and cost savings.

The ultra-low profiles of Svelte technologies also downsize catheters, facilitating TRI and direct stenting, further positively impacting the efficiency with which care is administered.

Unlike transfemoral access, where bed rest up to 6 hours following PCI is common, patients undergoing TRI are mobilized much faster, clearing bed space and enabling quicker time to discharge and enhancing throughput for the facility. Multiple studies have shown the ability of TRI to reduce time to hemostasis, ambulation and discharge7-9. And, patients treated via TRI typically have less need for assistance post PCI – there is no need for manual compression and typically less pain medication and/or physician consultation required during bed rest and recovery.

Svelte technologies are a new approach to PCI specifically designed to optimize TRI and direct stenting.

Reducing procedure time and material use, optimizing use of hospital overhead and improving patient experience add value to healthcare.

Redefining Best Practices

Focus in interventional cardiology historically was solely on improving patient outcomes – utilizing the best available resources, irrespective of cost, to achieve optimal clinical results. With better technologies and refined interventional techniques, however, achieving exceptional clinical outcomes is becoming more routine, allowing greater attention to be spent on resource optimization and cost reduction.

In fact, many hospitals have begun posting quarterly dashboards ranking each attending physician by their average cost of PCI to measure their procedural efficiency.

Use of the transradial approach has grown from less than 3% of PCI in the US in 2007 to approximately 30% today10, with adoption continuing to accelerate. It already is the recommended default strategy for PCI in Europe and much of Asia11.

The growth of TRI is driven in no small part by its ability to add value: reducing bleeding complications, time to patient ambulation and time to discharge, thereby optimizing use of hospital resources and increasing patient throughput.

And as proficiency with TRI is achieved, the development of outpatient programs for PCI is the next logical step, given the ability of TRI to improve patient satisfaction and bed turnover while reducing the cost of cardiac care.  In fact, same-day discharge is already occurring with increasing frequency in parts of Europe and North America where TRI is the current standard of care11.

The ability to enhance patient experience and facilitate outpatient procedures is shifting referral patterns in these areas, as empowered patients are increasingly aware of the therapeutic options available to them.

Patients undergoing TRI as opposed to intervention via transfemoral approach expressed strong preference toward TRI across most quality of life assessments4.  Those experiencing PCI via both methods, preferred TRI by 90%, while transfemoral was preferred by only 2% of patients (8% expressed ambivalence)4.  And for patients suffering from left ventricular dysfunction, lung disease, back and/or hip pain, the extended bed rest required to achieve femoral hemostasis is particularly poorly tolerated.

Ultra-low profile Svelte technologies allow physicians to downsize catheter size, reducing the risk of bleeding complications and enhancing patient comfort peri-and-post procedurally via TRI while reducing time to ambulation and better enabling same-day patient discharge, essentially redefining PCI best practices.

Svelte Technologies Create Value

Piscione et al chart graphic

Clinical Benefits of Direct Stenting

As the world’s lowest profile DES, SLENDER IDS attains crimped cross sectional area profiles approximately HALF those of conventional stents*, allowing allows the use of smaller catheters to facilitate TRI across wider subsets of patients and reduce risk of bleeding complications. Specialized design and materials also enable safe direct stenting across more challenging anatomy, which is associated with reductions in radiation exposure, death, MI and TLR3.

And as the only stent approved for use through diagnostic and smaller catheters (0.047” ID), SLENDER IDS gives operators the option to perform diagnostic angiography and seamlessly continue onto a therapeutic approach through the already engaged diagnostic catheter, simplifying PCI in appropriate lesions.

Though 50% of of investigators in Svelte clinical studies were 1st-time users of SLENDER IDS:

  • 74% of patients were treated via transradial approach
  • 96% of lesions were direct stented successfully
  • 98% of cases were free of device failure

SLENDER IDS also achieved:

  • Late lumen loss of 0.09 mm and 98% strut coverage at 6 months
  • 0% death, 0% stent thrombosis and exceptionally low TLR through 3 years

Downsizing catheters and extracting steps from stenting procedures contribute to:

  • Less material use during cases
  • Shorter procedure times
  • Greater patient throughput
  • Improved patient outcomes and experience
  • Reduced vascular access (bleeding) complications
  • Reduced length of stay / better utilization of beds
  • Same-day discharge

All of the above are tangible benefits of Svelte technologies.

Svelte combines the latest stent technologies and unique concepts to improve efficiency in coronary stenting.

Shorten Lab Time. Lower Procedure Cost. Improve Resource Management.

References:

  1. Valgimigli M et al. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial (MATRIX). Lancet. 2015 Jun 20. 385(9986): 2465-2476.
  2. Bernat I et al. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial (STEMI-RADIAL). J Am Coll Cardiol. 2014;63(10):964-972.
  3. Piscione F et al. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? results from a meta-analysis of 24 randomised controlled trials. 2010;96:588-594.
  4. Cooper C et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomized comparison.Am Heart J. 1999 Sep. 138(3 Pt 1):430-6.
  5. Amin A et al. Costs of Transradial percutaneous coronary intervention. J Am Coll Cardiol. 2013;6(8):827-834.
  6. Dobson, DaVanzo et al. Baseline statistics of acute care hospital readmissions by episode type for select MS-DRGs and chronic conditions: a working paper analysis commissioned by the Alliance for Home Health Quality and Innovation (AHHQI). July 18, 2012.
  7. Agostoni F et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44:349-56.
  8. Jolly S et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.Lancet. 2011 Apr 23. 377(9775):1409-20.
  9. Romagnoli et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome (RIFLE-STEACS). J Am Coll Cardiol. 2012;60:2481-9.
  10. Sunil Rao, Update on US transradial access adoption at TCT 2015.  Diagnostic and Interventional Cardiology, October 30, 2015.
  11. Kiemeneij F et al. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the european association of percutaneous cardiovascular interventions and working groups on acute cardiac care and thrombosis of the european society of cardiology. EuroIntervention. 2013;8: 1242-51.

 

* Data on file at Svelte.

 DIRECT I clinical study.

 DIRECT II clinical study.

 

CAUTION: The law restricts SLENDER IDS to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. SLENDER IDS is CE approved. DIRECT RX is an investigational device not approved for commercial use. SLENDER IDS and DIRECT RX are not available for sale in the US.