Medical Device Daily Associate
Bacchus Vascular (Santa Clara, California) reported the recent FDA 510(k) clearance of its next-generation product, the Trellis-8 Peripheral Infusion system.
The device is an advanced drug infusion catheter designed for the treatment of deep vein thrombosis (DVT) and arterial occlusions by enabling targeted delivery of clot-dissolving drugs. The clearance is, in particular, for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
"Interventionalists are demanding a tool to treat DVT efficiently and cost-effectively," said Thomas Fogarty, MD, the well-known Stanford (Palo Alto, California) cardiovascular surgeon and inventor and founder of Bacchus Vascular. "Our engineers designed the Trellis-8 to treat DVT in a single procedure and not require a hospital to invest in capital equipment," he added.
The Trellis-8 is an advanced drug infusion catheter with two occluding balloons, drug infusion holes between the balloons and mechanical drug dispersion capabilities. This pharmaco-mechanical combination enables isolated thrombolysis, or targeted delivery and increased penetration of clot-dissolving drugs (thrombolytics) into a blood clot.
The system, introduced through a small percutaneous incision, is disposable. Interventional radiologists and vascular surgeons are the primary physician specialties who would use the device, the company said.
This new system will supplant the prior-generation product, the Trellis Reserve drug infusion catheter, adding the DVT indication.
"The fundamental technology and the implications for the device are very similar [to the Trellis Reserve catheter]," said Director of Marketing David Gibel. However, he told Medical Device Daily, "it's much more durable than the previous generation device.'
Aside from its better durability, Gibel noted that the new system has the capability to be used in larger vessels. "The reason that's important is that in deep vein thrombosis, those veins are typically larger than the arterial side of the body."
The system can be used to treat vessels up to 16 mm in diameter vs. 10 mm for the Trellis Reserve catheter. On the arterial side, Gibel said the system also can be used for treatment of acute limb ischemia like its predecessor.
DVT is a blood disorder resulting from the formation of a blood clot (thrombus) inside a deep vein of the leg, commonly located in the calf or thigh. DVT occurs when the blood clot either partially or completely blocks the flow of blood in the vein. Patient symptoms include pain, swelling, and discoloration. The company estimated that there are between 400,000 and 600,000 new DVT cases diagnosed each year in the U.S. However, Gibel said he believes that number may be conservative and that this is a condition that is severely underdiagnosed. "Other people are quoting up to 2 million [new cases yearly] in the United States," he said.
The majority of patients diagnosed with DVT are treated with anticoagulation therapy alone. While this therapy reduces the risk of fatal pulmonary embolism and further blood clot formation, the underlying blood clot may remain and cause permanent vein damage and postthrombotic syndrome. Preliminary clinical data with other blood clot removal techniques indicates that early removal of venous blood clots as a compliment to anticoagulation improves patient outcomes including the reduction of post-thrombotic syndrome.
Currently, best medical therapy is the primary treatment mode, however, Gibel said he believes the company can change this and eventually drive more patients to an interventional approach. "What we're hoping is that interventional treatment for deep vein thrombosis will become much more accepted as an alternative to the way patients are treated today."
"The medical community is becoming more aware that advanced DVT treatment options are available," said Mahmood Razavi, MD, an interventional radiologist from Sequoia Hospital (Redwood City, California) who was involved in clinical studies of the device. "I expect interventionalists to increase their outreach within their hospitals and communities regarding the Trellis-8 and its implications for treatment of DVT."
Razavi will be presenting on Trellis technology for treatment of DVT at the upcoming Society of Interventional Radiology (Fairfax, Virginia) meeting in New Orleans on Friday.
Gibel noted that while the company also has developed two mechanical thrombectomy catheters: the Solera Plus, FDA-cleared for thrombus removal in occluded dialysis grafts; and the Fino, the subject of an IDE study for removing venous clots that cause DVT, the company has no plans to sell either of these at this time. "What we've done is focus[ed] our efforts on the Trellis platform," he said.
Bacchus Vascular is a venture-backed medical device company focused on the treatment of occlusive vascular disease.
The company has been able to conserve its cash, garnering a Series D round in 2003 for $25 million (MDD, July 9, 2003). Since Fogarty founded Bacchus Vascular in 1999, the company has raised close to $40 million.