Heavily calcified coronary lesions can resist standard balloon dilatation and compromise stent delivery, which is why interventional teams often turn to a rotational atherectomy system for vessel preparation. The INVAMED TemREN Rotablator is a rotational thrombectomy and atherectomy system that uses high-speed burrs to grind and remove calcified plaque, supporting better lumen expansion ahead of stent placement. This overview covers TemREN's burr technology, speed range, and control features for interventional cardiology teams.
What Is the TemREN Rotablator?
TemREN is designed to address a specific and persistent challenge in percutaneous coronary intervention: lesions that cannot be adequately crossed or dilated with standard balloon catheters due to significant calcification. The system's diamond-coated burrs are intended to ablate calcified plaque while preserving surrounding elastic tissue, helping prepare the vessel wall for subsequent balloon angioplasty and stenting.
Rotational atherectomy is generally indicated for heavily calcified coronary lesions that resist conventional approaches. TemREN is positioned within INVAMED's coronary artery disease and cardiac interventions portfolio as the dedicated plaque-modification tool for this lesion subset.
What Burr Sizes and Materials Does TemREN Offer?
The TemREN system uses a System Advancer, which allows multiple burr-sized catheters to be used independently during a single case as the operator escalates burr size based on lesion response. Burr sizes range from 1.25 mm to 2.50 mm, giving operators a versatile selection to match vessel diameter and lesion severity.
Depending on the specific model, burrs are constructed with either:
- Diamond-coated abrasive surfaces, or
- Tungsten-carbide abrasive surfaces
The shaft is built from stainless steel or nitinol with a torque-transmitting core, intended to support consistent rotational energy delivery from the drive unit to the burr tip throughout the case.
What Is the Rotational Speed Range of TemREN?
TemREN operates across an approximate rotational speed range of 60,000 to 200,000 rpm, depending on the clinical scenario and operator preference. This range is intended to give physicians flexibility in calibrating ablation intensity to lesion characteristics, balancing effective plaque modification against the goal of preserving healthy vessel architecture.
Rotational speed and burr advancement are managed by the operator throughout the procedure, and the specific technique used in any case is determined by the treating interventional cardiologist based on lesion morphology and procedural response.
What Digital and Control Features Does TemREN Include?
TemREN incorporates connectivity features intended to support modern catheterization lab workflows:
- Bluetooth connectivity, enabling remote control via Android or iOS devices
- An embedded AI system designed to support data-driven operation during the procedure
These features are intended to give the operating team additional situational data and control flexibility during rotational atherectomy, without changing the fundamental mechanical principle of high-speed burr-based plaque ablation.
What Is the Intended Use of TemREN?
TemREN is intended for rotational atherectomy to remove calcified or fibrotic plaque in coronary or peripheral arteries, typically as a vessel-preparation step before balloon angioplasty and stent deployment. Use is restricted to trained healthcare professionals in an appropriate procedural setting. As with all interventional procedures, rotational atherectomy carries inherent risks, and patient suitability is determined by the treating physician following a full clinical evaluation.
Device availability and regulatory status vary by country. Please contact INVAMED or your authorized local distributor for current regulatory information applicable to your region.
Frequently Asked Questions
What lesions is the TemREN rotablator designed for?
TemREN is designed for heavily calcified coronary lesions that cannot be adequately crossed or dilated using standard balloon catheters, where plaque modification is needed before stent placement.
What burr sizes are available with TemREN?
TemREN burrs range from 1.25 mm to 2.50 mm, allowing operators to select an appropriately sized burr for the target vessel and to escalate size as needed during the procedure using the System Advancer.
Does TemREN replace balloon angioplasty?
No. Rotational atherectomy with TemREN is typically used as a vessel-preparation step for lesions resistant to balloon dilatation. Balloon angioplasty and stent deployment generally follow plaque modification, based on the treating physician's procedural plan.
Related INVAMED Resources
- TemREN Rotablator Product Page
- Coronary Artery Disease & Cardiac Interventions
- Contact INVAMED for Product Information
Medical Disclaimer: This article is provided for general informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendation. It is not a substitute for consultation with a qualified healthcare professional. Product indications, availability, and regulatory status vary by country. Always refer to the official Instructions for Use (IFU) and consult a licensed physician for guidance specific to your situation. INVAMED devices are intended for use by trained healthcare professionals.