TemREN
Atherectomy System

Ready to use set content provides a practical application option. Rotation speed can be adjusted easily and provide safe space to surgeon.


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Consistent Solution For Peripheral Arterial Disease

Ready to use set content provides a practical application option.
No additional installition equipment required before the process.
Rotation speed can be adjusted easily and provide safe space to surgeon.

TEMREN Atherectomy system is an Atherectomy catheter advanced over a motorized wire. MEDDEV is a Class III Medical-Surgical product (which can be used inside the body in surgeries) with the qualifications required by the “EU Directive” No. 2.7.1 and 93/42/EEC. The Invamed Atherectomy System is used to open the occlusions and stenosis that occur in the acute, subacute, and chronic periods, especially in arterial peripheral occlusions. The Invamed Atherectomy System offers a powerful, effective and safe solution, even for challenging stenosis. Invamed Atherectomy System, with its diamond tip structure, effectively cleans including extremely hard stenosis without damaging the vessel. Invamed Atherectomy System is compatible with 0.014” and 0.018” guide wires.

Detailed specifications

TemRENAtherectomy System

 Ready-to-use set content provides a practical application option. Easily adjustable rotational mobility provides the surgeon with a safe field of use.

Peripheral arterial disease (PAD) and critical limb ischemia (CLI) treatment TemREN is used to prepare the lesion area for balloon angioplasty and to relieve the heavy plaque load from atherosclerotic lesions.

TemREN usually consists of arteries with chronic total occlusions and severe calcification lesions, which are difficult to treat with plaque load with angioplasty.

TemREN helps to achieve the maximum lumen diameter for stent and balloon procedures.

 Atraumatic rotational distal tip ensures reliable operation

  • Allows movement over 0.014” guide wire
  • TemREN transfers torque in a ratio of 1:1 (distal/proximal) thanks to its flexible helical internal structure.

  • Atherosclerotic environment, in which the internal spiral aspirates are fragmented by the Archimedean Principle
  • Five cutting blades comprehend and treat all morphologies, including severe calcium.
  • Provides consistent and predictable cutting without increasing the cutting depth.
  • Treat severely calcified lesions up to 2 times more effectively.
  • 15000 rpm
  • Ready-to-use set content provides a practical application option.
  • No October installation equipment is required before operation.
  • The rotation speed can be adjusted easily and provides a safe space for the surgeon.

 

CLINICAL SUCCESS

TemREN Atherectomy device has proven its success in alternative treatments in patients with peripheral artery disease as a result of prospective early and mid-term studies conducted.1 In the studies conducted, it was proved that 92% of the patients who underwent Temren atherectomy achieved an average of 85-90% technical success in the vascular lesion clearance rate, while maintaining this rate up to 70% as a result of 12 months of follow-up.2.3 It was shown that the clinical success rate reached 80% in follow-ups conducted from 1 month to 1 year. With a low complication rate, which is often observed from 3% to 5%, TemREN Atherectomy has proven its reliability and acceptability in the clinic.4

  1. https://www.sciencedirect.com/science/article/abs/pii/
  2. https://www.europeanreview.org/wp/wp-content/uploads/
  3. https://www.jvascsurg.org/article/S0/fulltext
  4. https://journals.sagepub.com/doi/abs/
  5. https://www.jvascsurg.org/article/S5/fulltext
  6. https://www.jvascsurg.org/article/S4/fulltext

Figure 1 - A.Pre-atherectomy and B.Post Atherectomy

Figure 2 - Vascular image during the atherectomy procedure

 

Advantages of Temren Atherectomy

 

Provides the possibility of recanalization without disturbing the elastic recoil

By reducing plaque load, it contributes to longer-term primary and secondary clearance rates

The right to stent and surgical bypass is always reserved for the patient unless there are complications.

Patency rates in calcific lesions are higher than in primary stenting

Consistent Solution For Peripheral Arterial Disease

Ready to use set content provides a practical application option.
No additional installition equipment required before the process.
Rotation speed can be adjusted easily and provide safe space to surgeon

Order Number Device outer diameter Working Length Crossing Profile Guidewire Compatibility
VS1021 5.0 Fr 90 cm 1.8 0.014"
VS1022 6.0 Fr 90 cm 2.1 0.014"
VS1023 7.0 Fr 90 cm 2.4 0.018"
VS1024 5.0 Fr 135 cm 1.8 0.014"
VS1025 6.0 Fr 135 cm 2.1 0.014"
VS1026 7.0 Fr 135 cm 2.4 0.018"
VS1027 5.0 Fr 150 cm 1.8 0.014"
VS1028 6.0 Fr 150 cm 2.1 0.014"
VS1029 7.0 Fr 150 cm 2.4 0.018"