Medical Device Daily

While other companies have developed what has become a kind of de rigueur retrievable vena cava filter for pulmonary embolism (PE), one company believes that it has a device that can be successfully removed for a much longer time than anything else on the market. Additionally, it claims that it’s product design is better than anything that the big boys in the space have come up with.

Rex Medical (Conshohocken, Pennsylvania) is the company making these claims, and it reported last week that in an international clinical study it has been able to successfully retrieve its Option vena cava filter thus far at up to 107 days.

The company reported that 29 patients enrolled to date in that international study have been successfully implanted with the Option filter for the prevention of PE resulting from blood clots or deep vein thrombosis (DVT), under the direction of Adrian Ebner, MD, chief of interventional procedures and cardiovascular surgery, French Hospital (Asuncion, Paraguay).

In several patients evaluated for retrieval, the filter was successfully retrieved most recently at times ranging from 84 to 107 days following filter implant by Anthony Venbrux, MD, professor of radiology and surgery, director, cardiovascular & interventional radiology at George Washington University (Washington).

PE occurs when thromboemboli become dislodged from the deep veins located in the legs and travel through the blood stream to the lungs. If left untreated, PE has a mortality rate in excess of 30%.

The Option filter is designed to remain either permanently in place or to be removed from the patient if the doctor determines the patient is no longer at substantial risk for PE.

“The big buzz in the industry today is the ability to retrieve these filters,” Lindsay Carter, VP of sales and marketing at Rex, told Medical Device Daily. “The fact that you’re able to take these implants out when the patients is not at risk is a very big deal. If you’re not retrievable and you’re entering the marketplace, you’re not going to go anywhere.”

Carter said early on that the company knew that it had to develop something better than a “me-too” product to compete with the larger players in the $250 million vena cava filter market. These biggies include Cordis (Miami Lakes, Florida), Cook (Bloomington, Indiana) and CR Bard (Murray Hill, New Jersey).

“We have to come out with something on the market that’s significantly better,” he said.

Aside from what he said are the company’s use of the view of thought leaders in the development of these filters — terming them “the filter gurus” — he noted that the Rex instrument has the lowest profile of any device on the market at 6Fr.

Additionally, Carter said that the Option has the largest cable diameter range. “We can cover the widest range of vena cavas up to 32 mm. Nobody else can cover up to 32 mm. The largest is 30 mm by Cordis.”

He noted too that the device’s nitinol construction allows for precise delivery of the device and “zero migration” once the filter is in place.

There is active interest in the Option from some of the big players, Carter said, noting that Rex is in the “final stages with a lot of big companies right now,” including Cordis.

What will cause the vena cava market to explode, Carter said, are new opportunities to use the devices in bariatric patients, orthopedic patients — particularly in hip and knee replacements — and trauma patients.

“That’s why retrievable filters are going to play a big role in the future,” he said.

A prospective, multi-center clinical study (10 sites, under 100 patients), approved under an investigational device exemption (IDE) from the FDA, is planned to begin early in February to collect data to support the filter as a permanent and retrievable device.

Matthew Johnson, MD, associate professor of radiology at Indiana School of Medicine and chief, vascular and interventional radiology, Clarian Health Partners (both Indianapolis), will be the lead investigator.

The company noted that extensive pre-clinical study data collected and analyzed in support of the clinical studies demonstrated excellent filter performance, including effective self-centering complete clot resorption at 90 days, and no migration or adverse events associated with filter implantation and retrieval up to 90 days. All implanted filters were successfully retrieved.

The IDE trial, Carter said would “take on all comers,” including the aforementioned uses in bariatric, orthopedic and trauma patients, and will have two arms: one for permanent filter placement and one for retrieved devices.

“Hopefully, [that study] is concluded by the third or fourth quarter of this year, and we can make it commercially available,” he said. He added that Rex is seeking to make marketing claims that the device can be retrieved “up to 100 days.”

While the company is a small entity, purely angel-funded, it is developing more than the Option filter and is developing devices for several disease states. These, in addition to the cardiovascular market, it is working on minimally invasive devices, either commercialized or under development, in oncology, venous access and endosurgery.

Venous thromboembolic disease is a leading cause of morbidity and mortality in the U.S., with PE being the most severe complication of the disease. PE is the third leading acute cardiovascular cause of death in the U.S. resulting in as many as 240,000 deaths annually.