TemREN Peripheral Atherectomy System

A rotational or directional atherectomy device specialized for plaque excision in peripheral arteries, augmenting lumen restoration while minimizing barotrauma.

Revolutionizing Vascular Treatment: TemREN Atherectomy for Precision and Control

  • Type: Rotational Atherectomy Device
  • Adjustable Speed: Customizable rotational speed for tailored treatment.
  • IVUS Compatibility: Compatible with Intravascular Ultrasound for enhanced visualization.

Empower Your Practice with TemREN: Atherectomy at its Smartest

  • Control: Bluetooth connectivity for remote control via Android and iOS devices.
  • Artificial Intelligence: Embedded AI system for smart, data-driven operation. TemREN 
    delivers smart, data-driven operation, further enhancing its precision and reliability.

TemREN Atherectomy: Where Innovation Meets Patient Care

  • Guidewire Compatibility: Operable with both 0.014 and 0.035 guide wires.
  • Aspiration Feature: High-powered aspiration for effective removal of debris.
  • Material: Durable and biocompatible construction.

• Method of IVUS analysis of calcium reduction. Pre-treatment IVUS (A), and the corresponding post-atherectomy IVUS (B). • The analysis sequence is shown at the bottom. • After identifying and matching the slices with calcium reduction, the lumen borders for both pretreatment (blue circle: lumen area=5.0 mm2) (C) and post-atherectomy images (green circle: lumen area=19.5 mm2 ) were contoured; and the two were overlaid. By comparing the two contours to the visual assessment of plaque, lumen gain (14.5 mm2) could be attributed automatically.

Early outcomes of novel Temren atherectomy device combined with drug-coated balloon angioplasty for treatment of femoropopliteal lesions The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) estimated that the was 92.3%. Combined use of Temren RA with adjunctive DCB is a safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

General Product Specifications

Specification Detail / Value
Product Name TemREN Peripheral Atherectomy System
Intended Use Minimally invasive plaque excision in peripheral arteries (e.g., femoral, popliteal, tibial) for PAD management
Atherectomy Mechanism Rotational or directional cutting tip with torque transfer shaft
Material Stainless steel or nitinol shaft, specialized high-hardness cutting burr or blade
Rotational Speed Range Typically 40,000–100,000 rpm (depends on burr size and specific model)
Cutter Diameter Range ~1.5–2.5 mm (small vessel) up to ~3.0–4.0 mm for larger peripheral vessels (if available)
Working Length ~80–150 cm (depending on product code)
Guidewire Compatibility Usually 0.014” or 0.018” (verify actual design)
Sheath Compatibility ~5F–7F introducers, depending on burr diameter
Saline Infusion Some models allow continuous saline flush near the cutting tip to reduce friction and debris
Control Console or Handpiece Proprietary TemREN drive unit or universal rotating system, depending on final specification
Sterility Sterile (Ethylene Oxide)
Single Use Yes
Shelf Life ~2–3 years if stored at 15–25 °C in sealed packaging
Clinical Indications PAD lesion debulking, moderate to severe calcified plaques, occlusive disease in SFA or popliteal territories
Contraindications Extremely tortuous or dissected vessels, risk of distal embolization in highly unstable plaques, etc.

TemREN Peripheral Atherectomy

Cutter Dia (mm) Working Length (cm) Sheath Rec. (F) Speed Range (rpm) Product Code Notes
1.5 80 5F 40k–80k TMPA-1.5-80-5F Smaller burr for below-the-knee or distal lesions
1.5 100 5F 40k–80k TMPA-1.5-100-5F Extended length for deeper tibial access
2.0 80 6F 50k–90k TMPA-2.0-80-6F Common size for femoropopliteal region
2.0 120 6F 50k–90k TMPA-2.0-120-6F Longer approach for diffuse SFA disease
2.5 80 6F 60k–100k TMPA-2.5-80-6F More aggressive plaque removal in moderate vessels
2.5 120 6F 60k–100k TMPA-2.5-120-6F Extended length for multi-segment occlusions
3.0 80 7F 60k–100k TMPA-3.0-80-7F Larger burr for heavily calcified femoral arteries
3.0 120 7F 60k–100k TMPA-3.0-120-7F Extended for more proximal SFA or iliac usage
3.5 80 7F 60k–100k TMPA-3.5-80-7F High diameter burr for large vessel debulking
3.5 120 7F 60k–100k TMPA-3.5-120-7F
4.0 80 7F or 8F 60k–100k TMPA-4.0-80-7F Max burr diameter for wide peripheral vessels
4.0 120 8F 60k–100k TMPA-4.0-120-8F Extended approach for extensive plaque areas

TemREN represents a front-cutting atherectomy device engineered to mechanically debulk and clear plaque within peripheral arteries—especially in challenging PAD (Peripheral Arterial Disease) lesions. By combining low-profile design, direct lesion access, and reduced vessel trauma, TemREN is poised to enhance both efficacy and procedural confidence in the endovascular management of systemic atherosclerosis.

Front Cutter
  • Direct Lesion Debulking: The front-cutting mechanism addresses atherosclerotic tissue at the lesion core, reducing the need for nosecone passage prior to cutting.
  • Minimized Vessel Trauma: By precise plaque shaving rather than forceful pushing, the cutter design aims to lower shear stress or vessel dissection risk.
  • Enhanced Deliverability: A streamlined catheter shaft navigates through tortuous pathways without unnecessary friction, improving trackability and pushability.
  • Wire Guidance: The over-the-wire approach allows stable lesion crossing, facilitating accurate lesion engagement and device alignment.
  • Mechanical Atheromatous Removal: Atherectomy can diminish plaque burden while preserving or maximizing native vessel patency, potentially limiting adjunctive stenting.
  • Optimized Physiologic Remodeling: By clearing plaque from the lumen, flow dynamics are restored with lower reliance on metallic implants.
  • Femoral, Popliteal, and Infrapopliteal Vessels: Suitable for a range of peripheral segments typically subjected to high shear stress from stenting or angioplasty alone.
  • Adjunct to Balloon Angioplasty: Enhances the efficacy of subsequent balloon dilation or drug delivery.

Technical Specifications

Specification Detail / Value
Product Name NeuroScope Neuromonitoring (Invamed)
Signal Modalities EEG, EMG, EPs (SSEP, MEP), optional BAEP (Brainstem Auditory Evoked Potentials)
Sampling Rates Up to ~10 kHz (per channel), adjustable depending on signal type and clinical use
Amplification & Filter Low-noise amplifiers (<1 µV RMS); customizable filter settings for notch, bandpass, or artifact suppression
Channels 8–32 input channels standard; expandable to higher channel counts as needed
Connectivity USB/Ethernet for data export and real-time remote viewing; optional HL7 or DICOM integration
Operating Interface Touchscreen workstation with intuitive GUI; multi-tier alarm thresholds for amplitude, latency, or EEG power
Electrode Compatibility Standard surface electrodes, subdermal needles, or specialized depth/epidural leads; multiple adaptor cables supported
Sterilization (For Sensors) Single-use sterile EEG/EMG needles or re-sterilizable surfaces leads; verify local product codes and instructions

System Configuration & Ordering Matrix

Model Channels Monitoring Modalities Included Accessories Product Code Notes
NeuroScope Basic 8 EEG + EMG (basic EP support) 8-channel amplifier, basic electrode pack, touchscreen console NS-8-EEG-EMG Ideal for smaller centers or standard intraoperative sessions
NeuroScope Advanced 16 EEG + EMG + SSEP/MEP 16-channel amp, advanced EP kit, large console w/ multi-monitor NS-16-EEG-EMG-SSEP Balanced for most neurosurgical/spine interventions, includes EP leads & cables
NeuroScope Premium 32 Full EEG + EMG + EP suite (BAEP optional) 32-channel amp, extended EP sets, network integration console NS-32-EEG-EMG-EP Handles complex multi-modality monitoring; recommended for specialized neuro or major spine centers