Novel Distal Embolic Rotection Device
Vascular / Interventional Radiology
Sweeper-V is a novel double filter Distal Embolic Protection Device (DEPD) to limit the occurrence of atheroembolism. DEPDs are devices that are positioned past the lesion site in order to prevent emboli that may be dislodged during an angioplasty procedure that can cause distal organ embolizations. Microemboli occur in all peripheral arterial interventions in varying degrees. distal embolisation has been documented in 55–100 % of cases.
There are two general types of DEPDs: filterbased devices and balloon-occlusion devices. Our novel device, the Sweeper-V is a “double-filter”based device
Filter-based devices are more widely used by interventionists; they work by deploying a mesh distal to the lesion. The mesh filter contains pores approximately 100 µm in diameter to allow blood flow, but at the same time to trap emboli. The benefit of DEPD use is becoming more accepted due to the significant clinical consequences of distal embolisation during the angioplasty procedures.
Innoventions developed a novel method for a rapid and low cost production process for a filtering device that can be easily manufactured and modified for capturing and removing embolic particles of various sizes during angioplasty procedures. The pores of the Sweeper-V are 80–130 um. At the end of the angioplasty procedure the canopy of the Sweeper-V is constricted over the trapped embolic particles and retrieved.
Percutaneous angioplasty and/or stenting is increasingly being used as an alternative to surgery for artery revascularization. Since distal embolisation of organs during angioplasty procedures is known to require invasive treatment and even result in organ loss, the concept of trapping debris and preventing such distal embolisation is becoming more popular. This is mainly because its use have shown to improve patient outcomes in arterial vascular interventions. DEPDs when treating peripheral artery lesions should be considered when feasible.
Embolic protection using filter-based DEPDs allow for a more aggressive approach to acute arterial occlusions.
Differing from the balloon shaped DEPDs, filter baskets are net-like structures that are positioned past the lesion site in order to catch emboli that may be dislodged during an angioplasty, but at the same time allow blood to continue to flow through the artery during the procedure.
Filter DEPDs have shown extremely high emboli capturing efficiencies. They prevent embolic material from traveling through the bloodstream.
Slight modifications of the Sweeper-V enables its use in the GI tract for removing stones from the common bile duct and as an antiretropulsion device in the urinary tract during endolithotripsy procedures.
Several Prototypes produced
According the Global Forecast to 2023", published by MarketsandMarkets™, the global embolic protection device market was valued at USD 373.0 Million in 2017, it will reach to 405.5 Million in 2018,and projected to reach USD 604.9 Million by 2023 at a CAGR of 8.3% during the forecast period.The growth in this market is mainly attributed to factors such as the rising incidence of cardiovascular and neurovascular diseases, growing funding and investments launch of technologically advanced embolic protection devices, and the rising demand for minimally invasive procedures.
The favorable medical reimbursement scenarios for neurovascular procedures in developed countries, increasing awareness about the clinical efficacy of embolic protection devices among neurosurgeons, and the rising adoption of these systems across developing countries (such as China and India) are expected to drive the growth of this application segment during the forecast period.
Renal artery stenosis (RAS) secondary to atherosclerotic vascular disease is becoming increasingly common as the population ages. RAS is a progressive condition that can lead to refractory hypertension and renal insufficiency that can cause severe or persistent hypertension, ischaemic nephropathy with chronic kidney disease and cardiac disturbance syndromes (i.e. flash pulmonary oedema and acute coronary syndromes).