The patients included in this study were relatively complex, often presenting with multiple co-morbidities (Table 1). The mean age of patients was approximately 74 years, with 62.2% having current or past tobacco use. In addition, 74.7% of patients had diabetes mellitus and 60.8% had a history of coronary artery disease. Over half of patients (55.2%) had a history of renal failure, with 44.8% of patients having active dialysis at the baseline assessment. Of the 126 patients with data from Rutherford category assessment completed (Fig. 1), 33.3% at baseline were observed with chronic limb-threatening ischemia (CLTI, Rutherford 4–6).

Clinical improvement measured by Rutherford Category and ABI improvement at 6-month follow-up. Rutherford category was assessed at: a baseline (N = 126 patients) or, b 6-months follow-up (N = 97 patients). 89.0% of patients (81/89) with Rutherford category assessments at both timepoints improved by ≥ 1 when compared with preprocedure without TLR. c ABI was also assessed at each timepoint (N = 85 patients with data from both timepoints). Box and whisker plot (min, lower quartile, median, upper quartile, and max) displayed patient readings, with % change shown. 87.1% of patients had improved hemodynamics, which included those with ABI increase of 0.1 or more or a preprocedural ABI < 0.9 and follow-up visit ABI > 0.9 without the need of repeat TLR, compared with baseline

Atherectomy was utilized on these patients due to their severe lesion characteristics (N = 176 lesions, Table 2). Most lesions were in the superficial femoral artery (SFA), with 13.1% containing an ostial segment and 21.0% containing a proximal popliteal artery segment. Restenosis was implicated in 7.4% of lesions (13/176). The mean treated lesion length was 80.0 mm. Lesions were classified as TASC II C or D in 43.0% of cases, and all but one treated lesion was rated as severely calcified (99.4%).

Procedural success was achieved in 98.8% of procedures (158/160, Table 3): one procedure experienced bailout stenting, and another converted to stent graft placement, which occurred due to the guidewire passing into subintimal space causing a rupture that necessitated conversion. Jetstream devices included in this study were models SC1.6, SC1.85, XC2.1/3.0, and XC 2.4/3.4 models. For the procedures with the XC2.1/3.0 and XC2.4/3.4, 50.0% (15/30) and 77.5% (86/111) were performed using expandable blades, respectively. The mean overall procedure time was 92.0 min with a mean device use time of 17.8 min. The mean luminal stenosis percentage following atherectomy was 33.7%. At the final assessment after the procedure, following atherectomy predilatation and PTA treatment, the mean luminal stenosis percentage was 10.1 ± 12.0%.

Procedural complications occurred in 7.1% of procedures (Table 3). The perforation and pseudoaneurysm cases were deemed procedural but not directly related to the tested device. The perforation case involved a guidewire being passed into subintimal space that resulted in vessel rupture. Site-reported distal emboli on the day of the procedure had an incidence of 5.8% (9/154). Of these, 2 cases were scored as related to tested device. Two distal emboli cases were not resolved or resolving with complication: one patient experienced pain and difficulty walking during resolution that showed improvement with local intra-arterial injection of nitrol and alprostadil, and another patient had catheterization attempted but was unsuccessful. The remaining cases resolved or were resolving without complication. We compared distal embolization cases to other patients for investigating potential risk factors (Suppl Table 1). Patients who experienced distal embolization trended slightly older (79.6 vs 74.0 years) with no notable differences in other categories; the distal embolization sample size limited statistical assessment.

Perioperative outcomes assessed by lesions treated showed 97.1% leveraged PTA with a drug-coated balloon. A total of 96.6% of lesions met the criteria for success (169/175); of those that did not, five of the six unsuccessfully treated lesions were due to residual stenosis > 30%, and the final case involving a vascular perforation which was not attributed to the tested device as discussed above. Through this PMS, there were 10 device deficiencies reported from 304 devices used across 9 patients, which included difficulty of removal (N = 1), failure to advance to the lesion (N = 1), blades not spinning (N = 2), audible noise (N = 1), connection issues (N = 3), and device failure to prime (N = 2).

Antiplatelet medication information was available for 35 patients. No patients were reported to be without antiplatelet medication at discharge or at 6 months. Of the 27 patients with information available at 6 months, aspirin (63.0%) and clopidogrel (48.1%) were the most commonly reported medications.

Patients were tracked longitudinally, and 6-month outcomes are included in this report. Primary patency was 87.5% and the freedom from TLR was 98.8% after 6 months by Kaplan–Meier analysis (Table 4). Rutherford category was assessed at both baseline (Fig. 1a, N = = 126 patients) and 6 months (Fig. 1b, N = 97). A total of 89.0% of patients showed sustainable primary clinical improvement of ≥ 1 without intervention (including TLR) after 6 months. ABI was significantly improved at 6-month follow up above baseline (p < 0.001) and saw a 33.6% increase from baseline, from a median of 0.70 preprocedure to 0.94 at 6-month follow-up. Improved hemodynamics were documented in 87.1% (74/85) of patients with data for both timepoints. One major amputation occurred in a patient classified as Rutherford 3 due to necrosis of the first right toe with a refractory ulcer that developed three months after procedure attributed to worsening of pre-existing disease. Three other patients had minor amputations reported during the study period. The causes of minor amputations included refractory ulcers by right CLI, black necrosis observed, and gangrene spreading with infection requiring drainage, respectively. The all-cause mortality rate observed was 7.8% of study participants after 6 months.