Eight months after closing a $220 million deal to buy Rita Medical Systems (Fremont, California), AngioDynamics (Queensbury, New York), has launched the Rita UniBlate — a device that CEO Eamonn Hobbs says “further solidifies” the company’s leadership in the market space.
AngioDynamics, a provider of devices used by interventional radiologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, describes the Rita UniBlate as a “scalable, single-needle radio frequency ablation electrode used to coagulate lesions during percutaneous, laparoscopic, and intraoperative surgical procedures.”
The company bought Rita Medical Systems for $220 million at the end of January (Medical Device Daily, Jan. 31, 2007), including the assumption of about $3.3 million of Rita’s net debt.
The UniBlate features a single, 17-gauge cannula electrode with a scalable active tip length of 1 to 2.5 centimeters. Hobbs told Medical Device Daily that this feature allows the physician to perform multiple ablations with the same electrode.
“The UniBlate is unique in that it offers the availability of doing scaled ablations with one needle, which none of our competition provides,” Hobbs said.
Because the device allows the physician to use the same needle for multiple-sized ablations, Hobbs said it reduces the number of items the physician has to keep in inventory.
The physician can adjust the length of the active electrode to ablate areas between 1 and 3 centimeters in length and 1 and 2.5 centimeters in diameter, reducing the need to switch electrodes during a multiple ablation procedure.
Hobbs also told MDD that the single needle design provides an added level of safety for ablations that are needed near critical and delicate structures, when multi-tine electrode arrays are less desirable. With the UniBlate, AngioDynamics said it now provides interventional radiologists, oncologists, and surgeons a full line of RF devices capable of ablating a variety of lesions from 1 to 7 centimeters in diameter.
“The UniBlate enables the successful treatment of small tumors located in critical anatomical areas,” said Riccardo Lencioni, MD, a professor of radiology at the University of Pisa (Pisa, Italy). “In our practice, we see a number of patients with small liver or lung tumors in very difficult locations, where placement or deployment of an electrode array may be technically challenging. We have treated these patients safely and successfully with the UniBlate.”
Peter Mueller, MD, a professor of radiology at Harvard Medical School (Boston) and head of abdominal imaging and interventional radiology at Massachusetts General Hospital (Boston), agreed that the UniBlate has become a valuable tool.
“The electrode’s small footprint is useful for treating lesions in difficult anatomic locations and its powerful profile allows us to treat lesions in a variety of organs,” Mueller said.
AngioDynamics has begun a limited commercial launch of UniBlate and expects full market launch on Nov. 1. The company received 510(k) clearance from the FDA in February, Hobbs said.
“The Rita line of RF ablation devices is the market leader and is well known among surgeons and interventionalists for its clinical efficacy,” Hobbs said. “The UniBlate strengthens this offering by providing physicians with greater flexibility and safety in small lesion ablations. We have been delighted by the enthusiasm with which physicians have welcomed the UniBlate, and we are very encouraged by the clinical benefits that have been demonstrated in early cases. We look forward to its full commercial launch in November.”
Lencioni will be presenting data on his early clinical experience with the UniBlate at the Cardiovascular and Interventional Radiological Society of Europe (Vienna, Austria) annual scientific meeting in Athens, Greece next month.
“We don’t give guidance on individual products but this is a significant product for us both in the U.S. and international market place,” Hobbs said.
AngioDynamics’ product line includes radio frequency ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products.