I’ve recently partnered with Becton, Dickinson and Company (BD) to analyse the budget impact their Rotarex™ S atherothrombectomy system has on the treatment of femoropopliteal in-stent restenosis. This article summarises the key findings of the published study and provides a few takeaways on its implications for the economic evaluation of medical devices.
The clinical and economic context
Femoropopliteal in-stent restenosis (FP-ISR) is a significant and growing clinical challenge. Around 40% of bare-metal stents in the femoropopliteal segment will exhibit restenosis within one year, rising to 60% after three years, and up to half of all patients who receive femoropopliteal stents will ultimately require secondary interventions. Current guidelines don’t offer strong treatment recommendations and there is no expert consensus on the standard of care.
Arterial bypass surgery remains a feasible treatment strategy but is associated with longer hospital stays, higher mortality and considerable resource use. However, an emerging evidence base supports the safety and efficacy of percutaneous mechanical atherothrombectomy (PMA) devices — particularly for patients with complex lesions or those unfit for surgery.
Using time-driven activity-based costing to take a provider perspective
The majority of published budget impact analyses of medical devices adopt a payer perspective, typically using national tariffs or diagnosis-related group payments to estimate costs. This approach is, of course, aligned with the needs of health technology assessment (HTA) bodies, but is much less informative for healthcare providers that need to not only understand the cost-savings a device could deliver but how it changes a treatment pathway.
The model I developed used time-driven activity-based costing to map two complete treatment pathways — one for arterial bypass surgery under general anaesthetic versus another for endovascular recanalization as a day case under local anaesthetic. The entire pathway was mapped in detail, starting with the patient’s referral to a rapid access vascular clinic through to their final follow-up appointment. These maps were then combined with the unit costs for each professional involved each step in each pathway.
Key findings
The analysis estimated a per-patient cost saving of £4,750 for endovascular recanalization with PMA compared with bypass surgery. Applied to a base case of 12 FP-ISR patients per year with a 50:50 intervention mix, this translated to a total budget impact of £142,497 over the model’s five-year time horizon.
The total surgical pathway cost was £9,927 per patient, comprising the procedure (£2,708), six days of inpatient care (£3,770), delayed discharges (£937) and surgical complications (£1,700). By comparison, the endovascular pathway cost was £5,177 per patient. Although the catheter set (£3,600) made the endovascular procedure itself more costly than surgery, this was more than offset by the elimination of inpatient stays, delayed discharges and the lower complication profile.
Sensitivity analysis confirmed that the cost savings were highly robust. The three most influential parameters were post-surgery length of stay, delayed discharges and operating theatre utilisation. The endovascular pathway was cost-saving even at a post-surgery length of stay of just two days.
Scenario analysis demonstrated the breadth of the model’s applicability. A vascular service with a bypass-first orientation, short post-surgery stays and low FP-ISR incidence still achieved a five-year saving of £13,630. A service with high ISR rates and lengthy post-surgical stays achieved a saving of £654,253, with over 1,100 inpatient bed days and 300 operating theatre hours released.
Implications for economic evaluation in medtech
These findings illustrate the value of conducting provider-perspective evaluations alongside, or in addition to, the payer-perspective analyses that are ubiquitous in HTA submissions. The granularity of activity-based costing revealed that the dominant cost drivers were not the device or procedure costs themselves but the downstream resource consequences: inpatient bed days, delayed discharges and theatre capacity. These are precisely the resource pressures that vascular services are managing on a daily basis, and precisely the variables that a tariff-based model would aggregate away.
This is particularly relevant in the current NHS environment. The National Vascular Registry reports that endovascular procedures overtook bypass surgery volumes in 2019 and that the gap has continued to widen. At the same time, the vascular surgery workforce is shrinking — experienced surgeons are being lost to retirement and burnout. In this context, technologies that can shift procedures from the operating theatre to the cathlab, from inpatient stays to day cases, and from general to local anaesthetic, have economic implications that extend well beyond the direct cost of the device.
The provider and payer perspectives are complementary. A payer-level analysis addresses the question of whether a technology represents an efficient use of health system resources while a provider-level analysis addresses a different but equally important question: what will this technology mean for my service’s capacity, workflow and budget? For medical devices that reshape treatment pathways, both questions deserve rigorous answers.
Stanberry B, Maclean D, Elbasty A. Percutaneous mechanical atherothrombectomy versus arterial bypass surgery for femoropopliteal in-stent restenosis: a budget impact analysis. J Soc Cardiovasc Angiogr Interv. 2025 Jun 17; 4(6): 103616. DOI: 10.1016/j.jscai.2025.103616
