Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial

Shammas, Nicolas W.; Chandra, Pradeep; Brodmann, Marianne; Weinstock, Barry S.; Sedillo, Gino; Cawich, Ian; Micari, Antonio; Lee, Arthur; Metzger, Chris; Palena, Luis Mariano; Rundback, John H.; Investigators, Ex-Pad

doi:10.1016/j.carrev.2018.11.022

Cited by 18 publications

(16 citation statements)

References 11 publications

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“…112 Based on these results, laser atherectomy may have an additive beneficial effect in treating infrapopliteal lesions; however, the clinical efficacy and safety of each atherectomy technique for the treatment of infrapopliteal disease remains to be proven. [113][114][115] A subgroup analysis of only the patients with infrapopliteal disease from the prospective, multicenter DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk PerIpheral Plaque ExcisioN System for the Treatment of Infrainguinal VEssels/Lower Extremities) trial (ClinicalTrials.gov identifier: NCT00883246) demonstrated that directional atherectomy prior to BTK angioplasty resulted in favorable clinical and technical results. 116 This study included 145 patients [70 claudicants (48.3%) and 75 patients with CLTI (51.7%)] with an average 58±44-mm lesion length.…”

Section: Residual Stenosismentioning

confidence: 99%

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy

et al. 2020

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Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.

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Section: Residual Stenosismentioning

confidence: 99%

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy

et al. 2020

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“…21 Several strategies have been recently approved to treat FP ISR, including excimer and B-laser, covered stents, and DCBs. 1,4,5,14 Debulking with laser atherectomy of FP ISR yielded lower TLR rates at 6 months and 1 year when compared with angioplasty as seen in the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis), 5 with a mean lesion length of 19.6±12.0 cm. Rotational and aspiration atherectomy using the Rotarex S had a 1-year patency of 81.6% in treating FP ISR.…”

Section: Discussionmentioning

confidence: 99%

“…Excimer laser was been shown to reduce TLR at 6 months and 1 year when compared with BA alone, 5 whereas the B-laser was approved as part of a prospective, singlearm, investigational device exemption (IDE) study, the EX-PAD-03 trial, that included both de novo and restenotic infrainguinal lesions (including ISR). 14 The JetStream atherectomy device (Boston Scientific, Maple Grove, MN, USA) is a rotational cutter with aspiration capability that has proven very effective in debulking both atherosclerotic and restenotic tissues. [15][16][17][18] Prospective, core laboratory-adjudicated feasibility data on 29 patients (32 limbs) with FP ISR treated with the JetStream XC device showed no device-stent interaction and freedom from TLR of 86.2% at 6 months and 58.6%1 at 1 year with no drug-coated balloons (DCBs) used.…”

Section: Research-article2020mentioning

confidence: 99%

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Shammas

Petruzzi²,

Henao

et al. 2020

J Endovasc Ther

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Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

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“…Calcification is rarely seen in the venous system. Venous calcifications in the literature are mostly associated with the portal vein [35]. *Address all correspondence to: drmehmeterin@yahoo.com that disease.…”

Section: Clinical Propertiesmentioning

confidence: 99%

“…This device is equipped with an optical fiber and circumferential designed blades for transmitting laser energy. Calcifications, fibrotic atherosclerotic plaques, and re-stenotic tissues are removed with the aspiration catheter added to the system [37].…”

Section: Treatmentmentioning

confidence: 99%

Vascular Calcifications

Tüysüz¹,

Dedemoğlu²

2020

New Insight Into Cerebrovascular Diseases - An Updated Comprehensive Review

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Calcium-phosphate levels have an effect on the vascular wall. Calcium is a cation in human body. It is has a crucial effect on intracellular and extracellular mechanisms. Extracellular calcium levels are more than intracellular levels. In total serum, the calcium level is approximately 8.8-10.4. Parathormone and vitamin D regulate blood calcium levels. Phosphorus is more common than calcium in the human body. Most of the phosphorus is present in the skeletal system. Phosphorus level is approximately 2.5-4.5 mg/dl in blood. It is often observed calcification in cardiovascular system in some diseases such as chronic renal failure due to increased calciumphosphate levels. While the calcification seems in tunica intima layer of the vessel in atherosclerotic disease, it seems in tunica media layer of vessel in chronic renal failure with high uremic level. Vascular calcification is due to arterial stiffness, stenosis, and occlusion. Vascular and valvular calcifications are irreversible. Increased arterial stiffness destroys vascular compliance, causes left ventricular hypertrophy, and disrupts coronary perfusion. As a result, increased vascular calcification is associated with cardiovascular mortality.

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Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial

Cited by 18 publications

References 11 publications

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

Vascular Calcifications

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