Bycross Atherectomy Device: What It Is & The Clinical Evidence

If you treat peripheral arterial disease, you’ll know the moment a guidewire won’t pass a chronic total occlusion. Every device on the market claims to solve it differently. Bycross takes a genuinely different approach: a rotational atherectomy and aspiration catheter that can cross and debulk a lesion without needing wire passage first.

This guide sets out exactly what Bycross is, how it works, what the clinical trial and real-world case data actually show, and how it stacks up against the atherectomy systems most UK interventionists already know.

What is Bycross?

Bycross is a 6F bi-directional rotational atherectomy catheter used to revascularise chronically occluded or heavily calcified peripheral arteries. It’s manufactured by Taryag Medical in partnership with Plus Medica, with GAP Medical Solutions as the UK distributor.

The catheter consists of a motor-driven, flexible coaxial shaft with an expandable, atraumatic distal tip. That tip macerates calcified plaque and thrombus into small particles, which are aspirated in the same step through an integrated pump into a collection bag, so debris doesn’t embolise downstream.

The detail that sets Bycross apart from most rotational atherectomy devices is that if guidewire passage is not achievable, Bycross doesn’t need a guidewire to pass through the occlusion before treatment starts. The tip is designed to cross the lesion itself, then debulk it, which matters most in exactly the cases where guidewire passage is the whole problem.

Key specifications

• Sheath compatibility: 6F or larger introducer sheath
• Guidewire compatibility: standard 0.035″ or smaller
• Rotation speed: 2,000–4,750 rpm (low relative to competing systems)
• Expandable tip diameter: 1.9mm–4.7mm
• Shaft lengths: 50–130cm, for distal anatomy and contralateral access
• Power source: lithium battery, disposable as non-bio-hazard waste
• Capital equipment: none required — no console, no pedal, no non-sterile kit

Because the whole system is stainless steel with hub-to-tip radiopacity and runs on battery power, there’s no capital outlay for a hospital to adopt it, and no need for a dedicated theatre setup.

How Bycross works in practice

Bycross is introduced over a guidewire and advanced through the introducer sheath to the lesion. Unlike most rotational atherectomy devices, it doesn’t require the wire to have already crossed the occlusion. As soon as the tip contacts the lesion, the system advances actively into it, macerating calcified atheroma and thrombus as it goes.

The distal tip has an elastic nitinol wing that can be activated to bow outward, increasing the working diameter from 1.9mm up to 4.7mm for a second pass — this is the “two-stage” technique interventionists refer to in case reports: an initial pass with the wing closed, then a second pass with the wing extended for additional lumen gain.

Debris is aspirated continuously through the sheath via the integrated pump (up to 65cc/min with a 6F sheath, or 200cc/min with an 8F sheath), rather than being left to embolise or requiring a separate distal protection device. Contrast can be injected through the shaft or sheath, so the procedure can be run under standard DSA or, as one of the case studies below shows, entirely under ultrasound guidance.

The clinical evidence

Bycross has more published clinical data behind it than most comparably new atherectomy devices, including a formal CE pre-market approval study and several peer-reviewed case reports.

Case study: the CE pre-market approval trial

The pivotal evidence for Bycross is a prospective, multi-centre, non-randomised study published in CVIR Endovascular in 2023 (Tessarek & Kolvenbach), run across two German centres under supervision of the German Federal Institute of Drugs and Medical Devices (BfArM).

The trial treated 39 patients with 41 femoropopliteal and distal popliteal lesions, all with severe disease: mean lesion length was 125mm (range 30–450mm), mean stenosis was 96.4%, and the patient group included a high proportion of critical limb ischaemia (Rutherford IV–V). This was not a trial of straightforward, short lesions — it deliberately included the calcified, long, complex disease that other atherectomy trials tend to exclude.

The results:

• 95.12% acute procedural success (39/41 lesions), including 11 lesions (26.8%) crossed without any initial wire guidance
• 0% device-related major adverse events at 30 days
• 0% intraprocedural embolisation — with no distal embolic protection device used in any case
• 2.4% major adverse event rate at 6 months
• Mean residual stenosis of 5.7% at discharge, rising to 21.7% at 6 months, measured by duplex ultrasound
• Stenting was needed in only 29.26% of lesions — lower than the 53% provisional stenting rate reported in comparable atherectomy literature

The authors’ own comparison is worth noting directly: the EASE trial of the Phoenix atherectomy system reported a similar 95.1% success rate but a 16.8% six-month MAE rate, against 2.4% for Bycross, albeit on a less complex lesion set. The DEFINITIVE LE trial of SilverHawk/TurboHawk reported 3.8% distal embolisation even with distal protection in place, against 0% for Bycross with none.

Case study: ultrasound-guided thrombatherectomy in a complex real-world case

A published case report from Alfried Krupp Krankenhaus Rüttenscheid (Jacke & Nowak) illustrates how Bycross performs outside a trial protocol, in a genuinely difficult patient.

The patient was a 43-year-old woman with a homozygous factor V Leiden mutation, a long history of femoral occlusions, prior thrombectomy and bypass surgery, and a re-occluded thromboendarterectomy zone that duplex ultrasound showed to be a fibrotic, chronically occluded mass rather than a simple thrombus. Given her thrombophilia and surgical history, the clinical team specifically wanted to avoid another open procedure or a permanent stent.

The intervention was carried out entirely under ultrasound guidance, using Bycross in cross-over technique through an 8F sheath — first at low rotation speed, then at high speed, then with the nitinol wing activated for a further pass. Where the occlusion was too wide to fully capture, the operators used external ultrasound-probe compression to bring more material into the device’s working range, achieving additional lumen gain beyond what the device would typically manage alone. The procedure finished with a drug-eluting balloon rather than a stent.

At follow-up the next day: ankle-brachial index improved to 1.1, the treated zone showed triphasic flow on duplex, and the patient was symptom-free. No foreign body was implanted. The authors’ conclusion was that Bycross can be used safely under ultrasound visualisation alone, sparing the patient radiation exposure while giving the operator real-time confirmation of lumen gain.

Additional peer-reviewed case reports on in-stent restenosis (Isernia; Migliara) and on recanalisation in multimorbid vascular patients extend this evidence further and are available via the Bycross product page.

How Bycross compares to other atherectomy devices

UK interventional teams are most likely to already have experience with Boston Scientific’s Jetstream, Philips’ Phoenix, or Straub Medical’s Rotarex S. Here’s how Bycross sits alongside them.

The wireless crossing capability is the genuine point of difference. Jetstream, Phoenix and Rotarex S all still require a guidewire to have tracked through the occlusion before the atherectomy element does its work — the published CE trial data describes Bycross as the first atherectomy device able to achieve lesion passage without that initial wire crossing, which is exactly the scenario the trial’s 11 wireless-crossing lesions (26.8% of the cohort) were demonstrating.

On headline safety figures, Bycross’s trial data (0% intraprocedural embolisation, 2.4% six-month MAE rate) also reads favourably against Phoenix’s EASE trial (16.8% six-month MAE rate) — though the two studies weren’t run on matched lesion complexity, so that comparison is indicative rather than a direct head-to-head.

Against Jetstream and Rotarex S, the practical difference for a UK department is as much about infrastructure as clinical performance: both of those systems need a reusable console or drive unit, ongoing servicing, and ongoing wire management through the lesion. Bycross removes all three requirements, which matters most for complex CTOs where wire passage is the actual clinical bottleneck, and for smaller units that don’t want capital equipment tied up in a single device line.

FAQs

Is Bycross the same as an iVascular product?

No. Bycross is manufactured by Taryag Medical and is a separate product line from iVascular, though both are distributed in the UK by GAP Medical Solutions.

Does Bycross need a guidewire?

It’s introduced over a standard 0.035″ or smaller guidewire, but unlike most rotational atherectomy devices, it doesn’t need that wire to have already crossed the occlusion before treatment begins.

What lesions is Bycross indicated for?

Peripheral arterial lesions including calcified atheroma, chronic total occlusions, and fresh or old thrombus, across the femoropopliteal and infrapopliteal segments, as well as in-stent restenosis and aorto-iliac recanalisation.

Does Bycross require capital equipment?

No. It’s a fully disposable, battery-powered device with no console, pedal, or reusable drive unit needed.

What does the clinical evidence show?

A CE pre-market approval study (Tessarek & Kolvenbach, CVIR Endovascular, 2023) reported 95.12% acute procedural success, 0% intraprocedural embolisation, and a 2.4% major adverse event rate at six months, across complex femoropopliteal lesions averaging 96.4% stenosis.

GAP Medical Solutions is the UK distributor for Bycross. For product enquiries, IFU documentation, or to arrange a case demonstration, contact the team.