In an industry that can be as competitive as major league baseball in October, it's refreshing to find a medical device company that actually speaks rather highly about its main competitor &$8211; while still pointing out why its own technology is superior to said competitor's technology, of course.
Bovie Medical (Clearwater, Florida) is that kind of company. Bovie said it has submitted for FDA 510(k) clearance for its BOSS device, which is based on its saline enhanced sintered steel technology. The company said the device is designed for surgical applications where soft tissue bipolar coagulation is desired.
Rick Pfahl, VP of business development at Bovie, told Medical Device Daily that the BOSS delivers radio frequency (RF) energy, or electrosurgical energy, simultaneously with saline to perform coagulation of soft tissue and bone without charring the tissue or creating stickiness within the tissue, which he says is a clinical challenge. The company said the technology also results in reduced blood loss.
"There are other devices that use saline together with RF energy," Pfahl said. He noted that Bovie's main competitor is a private company out of New Hampshire, Salient Surgical Technology (Portsmouth) that has a similar technology but said that the difference between the two technologies is in the delivery. "They are dripping the saline from above down to a conducive metal surface to keep the metal surface moist with saline ... we are delivering the saline through the conducive metal surface to ensure that there is adequate saline between the metal surface and the tissue."
"They've got very good technology, we think we do too, we have a great deal of respect for them and what they're doing, we've just enhanced the delivery system in a way that makes a clinical improvement," Pfahl said.
Salient's surgical tools are based on its Transcollation technology. The company offers both bipolar and monopolar sealers.
The BOSS is based on technology acquired from Boston Scientific (Natick, Massachusetts) last year (Medical Device Daily, May 2, 2008). According to Bovie, the device will primarily be targeted towards orthopedic hip and knee reconstruction surgeries.
Late last year Bovie said it received FDA clearance to market its Saline Enhanced Electrosurgical Resection (SEER) tissue resection device intended for initial use in liver oncology surgery (MDD, Nov. 21, 2008). The SEER device uses conductive sintered steel as an electrode for RF for cutting and coagulation. The process involves delivery of RF current and sterile saline for resection and coagulation in surgical procedures. The BOSS is basically an extension of that technology, Pfahl said.
Earlier this year the company reported a 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection (MDD, May 21, 2009). The laparoscopic SEER is a line extension of the SEER device that Bovie launched earlier this year and will address the growing market of minimally invasive liver resection. According to the company, the laparoscopic SEER allows the surgeon to dissect and achieve hemostasis with a single device resulting in less instrument utilization and fewer instrument changes in a minimally invasive approach.
Bovie is a profitable company, it is publically held, and it operates in the black, Pfahl said. According to the company, saline enhanced surgeries reduce operating time while improving post-operative outcomes and shorten recovery time.
"In today's economic environment, where controlling medical costs is important, the BOSS technology meets the needs of patients, surgeons and hospitals," said Andrew Makrides, president of Bovie, in a company statement. "Reduced blood loss, shortened operating and recovery time makes the BOSS a technology product that targets a large and growing market."
According to Bovie the orthopedic hip and knee reconstruction surgeries are significant markets, with more than 1.3 million procedures performed in the U.S. each year. These procedures represent large and growing markets due to a more active and aging population, the company said, noting that the worldwide market is expected to exceed $500 million in 2009.