Members only
Regulatory information only:
These Instructions for Use documents are made available solely for regulatory and product-information purposes. These publications do not constitute an offer for sale, supply or other commercial distribution of the Lithonic™ Coronary Intravascular Lithotripsy (IVL) Catheter and Lithonic™ Coronary Intravascular Lithotripsy (IVL) Generator. Product availability is subject to applicable regulatory requirements and third-party rights and may vary by country.

These products may not be commercially offered or available in certain countries or territories.
 

LITHONIC™ IVL CATHETER and LITHONIC™ IVL GENERATOR INSTRUCTIONS FOR USE

The Lithonic™ Coronary Intravascular Lithotripsy (IVL) Catheter used in conjunction with Lithonic™ Coronary Intravascular Lithotripsy (IVL) Generator, is intended for pre-treatment delivery of high-pressure acoustic waves to difficult-to-treat calcified stenosis, including calcified stenosis where balloons would fail to fully expand or stents would fail to uniformly expand. Both the Lithonic™ IVL Catheter and Lithonic™ IVL Generator are CE approved.

Download Lithonic™ Coronary Intravascular Lithotripsy (IVL) Catheter Instructions For Use

Download Lithonic™ Coronary Intravascular Lithotripsy (IVL) Generator Instructions For Use

 

SUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) FOR USER

Should you want to receive the SSCP of the Lithonic™ Coronary Intravascular Lithotripsy (IVL) Catheter and/or Lithonic™ Coronary Intravascular Lithotripsy (IVL) Generator, please use the request form below.
This request will only be processed if you are a health care professional and clinical user of the device.

 

SSCP Request form for user:

The fields marked with * are mandatory.


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CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology products, including BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, RISE™ NC and RISE™ SC, BioMC™ and Lithonic™ are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix Alpha, BioFreedom, BioFreedom Ultra, Rise SC, BioMC and Lithonic are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.