Medtronic Launches FDA-Cleared OsteoCool RF Ablation System

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According to Medtronic, the OsteoCool RF Ablation System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and they are launching the device in the United States.

However, this news may not be surprising to some.  According to MedCityNews, the OsteoCool RF Ablation System was originally developed by Baylis Medical as a device for treating cancers that metastasize to the spine. Baylis Medical received 510(k) clearance for the original OsteoCool device in March 2012, a second version of the device in June 2015,  and a third version of the device in November, 2015.

Medtronic purchased the OsteoCool RF Ablation System from Baylis Medical on December 16, 2015 for an undisclosed amount. According to Medtronic, the two companies have decided to partner up in order to further innovate the OsteoCool System.

Radiofrequency ablation systems use probes that deliver targeted radiofrequency energy to destroy cancer cells. According to Medtronic, the OsteoCool System uses a pair of internally water-cooled radiofrequency probes to ablate cancerous legions in the spine that have metastatized from other cancers. The water cooling controls the temperature of the probes and prevents overheating of surrounding tissue during the procedure. The pair of bipolar probes in the OsteoCool System may also be used simultaneously and are available in various lengths, allowing for the OsteoCool System to be configured to accommodate a variety of patient and procedural needs.

According to StreetInsider, this means that the OsteoCool System is currently the only cooled radiofrequency (RF) ablation technology that offers simultaneous, customizable dual-probe capability to allow for procedural flexibility and repeatability.

According to its website, Minneapolis-based Medtronic, Inc. is a global leader in medical technology that employs over 40,000 people. The company develops, manufactures, and markets medical devices that include implantable pacemakers and cardioverter defibrillators (ICDs), heart stents and valves, spinal discs, insulin pumps, continuous glucose monitoring systems, deep brain stimulation, neurostimulation for chronic pain, and remote monitoring and diagnostic products for chronic disease management.

According to its website, Baylis Medical Company is a supplier of high-technology cardiology, endovascular, and oncology products. Some of the products developed by Baylis include RF Puncture Systems and Devices such as the NRG RF Transseptal Needle for transseptal punctures in cardiac and vascular tissue.



Show Wang
Show Wang is an associate in our Orange County office. In 2009, Mr. Wang graduated with a degree in Biomedical Engineering from Duke University, where he researched and built low-cost wireless ECG machines. After graduation, Mr. Wang worked at a hedge fund before helping a biomedical startup model the thermal profiles of surgically-implantable cooling chips. While attending law school, Mr. Wang spent some time at the USPTO as an examiner extern. Mr. Wang graduated from New York University School of Law in 2014. Mr. Wang was a summer associate with the firm in 2013, and joined the firm as an associate in 2014.
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