Answers of Atherectomy System Temren Atherectomy System

Illness and prevalence about disease

Peripheral arterial disease (PAD) in the legs or lower extremities is the narrowing or blockage of the vessels that carry blood from the heart to the legs. It is primarily caused by the buildup of fatty plaque in the arteries, which is called atherosclerosis. It is estimated that >200 million people have PAD worldwide, with a spectrum of symptoms from none to severe. Relatively uncommon among younger people, the prevalence of PAD rises with age and affects a substantial proportion of the elderly population (>20% in >80-year-old individuals).

Critical limb ischemia (CLI) is a severe blockage in the arteries of the lower extremities, which markedly reduces blood flow. It is a serious form of peripheral arterial disease or PAD, but less common than claudication. It is estimated that >200 million people have PAD worldwide, with a spectrum of symptoms from none to severe. Relatively uncommon among younger people, the prevalence of PAD rises with age and affects a substantial proportion of the elderly population (>20% in >80-year-old individuals).

Causes and symptoms of disease

PAD Causes

  • Blood vessel inflammation
  • Injury to the arms or legs
  • Changes in the muscles or ligaments
  • Radiation exposure

PAD Causes

  • Coldness in the lower leg or foot, especially when compared with the other side
  • Leg numbness or weakness
  • No pulse or a weak pulse in the legs or feet
  • Painful cramping in one or both of the hips, thighs, or calf muscles after certain activities, such as walking or climbing stairs
  • Shiny skin on the legs
  • Skin color changes on the legs
  • Slower growth of the toenails
  • Sores on the toes, feet, or legs that won't heal
  • Pain when using the arms, such as aching and cramping when knitting, writing, or doing other manual tasks
  • Erectile dysfunction
  • Hair loss or slower hair growth on the legs

CLI Causes

  • Age
  • Smoking
  • Diabetes
  • Overweight or obesity
  • Sedentary lifestyle
  • High cholesterol
  • High blood pressure
  • Family history of atherosclerosis or claudication


  • Pain or numbness in the feet
  • Shiny, smooth, dry skin of the legs or feet
  • Thickening of the toenails
  • Absent or diminished pulse in the legs or feet
  • Open sores, skin infections, or ulcers that will not heal
  • Dry gangrene (dry, black skin) of the legs or feet

What is features of Atherectomy 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.

How to treat and cure process

A process for removing an obstruction from a vessel with an atherectomy system comprises the following steps: Conventionally inserting into a vessel, into an obstruction, a flexible guide wire. In case of a tight obstruction, an auger-shaped flexible guide wire can be 65 8 rotated backward so that the auger section will screw and pull itself through the obstruction. Advancing over the flexible guide wire a rotary cor ing means located at a distal end of an atherectomy catheter. Advancing the rotary coring means to the obstruction and coring the obstruction. During the operation, the flexible guide wire and the flexible sleeve (if present) are prevented from being rotationally dragged by the rotary coring means.

Fluid can be delivered to the obstruction site through the flexible sleeve, around the atherectomy catheter. Such fluid can lubricate and cool the coring process and provide a medium for flushing particles of obstruction material into the atherectomy catheter, especially in conjunction with suction applied to the proximal end of the atherectomy catheter. The fluid may be radio-opaque to assist in x-raying the process. Before coring, fluid can also be delivered through the atherectomy catheter. The mechanical action of the rotary coring means and the flexible guide-wire on the cored obstruction material due to the relative motion between them enables the cored material into a continuous passage defined in the atherectomy catheter and around the flexible guide-wire. Removing the catheter containing the obstruction material out of the vessel.

The sequence of insertion of the components into the artery may vary depending on the nature and the location of the obstruction and the preferences of the medical staff. Additional steps may be added to assist the process. A standard guiding catheter, which is either straight or pre-formed, may function as a sleeve and be inserted into the vessel to assist in placing the flexible guide wire and the atherectomy catheter in the obstruction site. When an arterial obstruction is further blocked by a fresh blood clot, as is often the case in a heart attack, the flexible guide wire can usually be inserted through the clot and the atherectomy system can be used to first clear the clot, preferably while employing suction, and then to continue and core the underlying atherosclerosis erotic obstruction.

Therefore, the atherectomy system can be an effective tool in treating a heart attack, where the treatment will relieve the immediate threat to the patient's life and continue to provide a long-term correction to the condition that induced the attack. Differing strategies can be employed when dealing with the process of opening an arterial obstruction. Rotary coring means having an opening approximately equal in area to the artery's internal area can be chosen, however, this raises the probability of injuring the artery or of leaving a thin layer of obstruction material to hang ing on the arterial wall. Such a thin layer that has no structural integrity of its own may separate from the arterial wall and act as a flap of a one-way valve which may block the artery. An alternative strategy is to choose rotary coring means with an area of fewer than three-quarters of the area of the arterial lumen.

Coring the obstruction with such rotary coring means usually relieves the patient's symptoms and it leaves sufficient material for the obstruction to remain structurally stable, reducing the likelihood of creating a flap, and, using undersized rotary coring means the probability of injuring the arterial wall is also reduced, even when dealing with an eccentric obstruction. After the obstruction is cored it is also possible to further increase the lumen by angioplasty, however, this will introduce some of the undesirable side effects that are associated 4,883,458 9 with angioplasty, and the choice of strategy will depend on the patient's specific disease characteristics and the judgment of the medical staff.

Result and scientific studies

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.