Micrus Endovascular (San Jose, California) and Flexible Stenting Solutions (Eatontown, New Jersey) have partnered to develop a flow diversion technology to treat certain types of aneurysms.
Flow diversion is a fairly new approach in the treatment of large and giant aneurysms, which represent 15% to 20% of treated intracranial aneurysms.
Robert Stern, president/chief operating officer, told Medical Device Daily that, "We've been discussing publicly the need for potential flow diverter devices for three years. We've been looking at these technologies for longer than that. There are larger form aneurysms that need a treatment paradigm that's more advanced than coils. Coils are very safe and effective. These devices would be used in complicated cases. It's for a small subset of all aneurysm cases."
Treatment of aneurysms – a weak spot on a blood vessel in the brain that bulges out and fills with blood – can involve the use of tiny coils that fill the aneurysm sac, eliminating it from the cerebral circulation in a less invasive manner. But flow diversion is an even newer approach in which stent-like devices are placed in the parent vessel. They serve to divert blood flow away from the aneurysm so that it can heal.
A patient who needs treatment for an aneurysm is typically evaluated to determine if the bulge should be clipped surgically or if an endovascular procedure is warranted, one that coils the lesion. Micrus already makes a MicroCoil delivery system.
"If you think of a pipeline that has in the middle a softening of the walls," he said. "Those walls bulge outward, weaken and you get this hideous bump. What you want to do is bypass the bulging segment with a flow diverter. It takes the pressure off the vessel wall in that section and allows for the safe diversion of flow, giving you another opportunity to treat this. In the past they stented across and put coils in. In some cases, we still may need to use coils."
What Flexible Stenting brings to the table is technology that facilitates this flow diversion technique.
"If you have an outward-bulging or inward-bulging vasculature, the right-handed and left-handed design made by Flexible Stenting may bring unique flow diversion properties to the table," he said. "It's a very flexible design and should give us good wall coverage."
In the new deal, Micrus will handle the regulatory and clinical processes and will manufacture neurovascular products that emerge from this collaborative agreement.
The new Flexible Stenting Solutions platform will include a self-expanding stent design that will provide more accuracy in delivery; porosity and flow diversion control based on a unique design pattern; increased flexibility during delivery and post-placement vessel conformability; allow for post-placement coiling if necessary; and includes a special coating that is intended to reduce the potential for thrombogenicity and stenosis.
John Kilcoyne, chairman/CEO of Micrus Endovascular, said, "We expect that our jointly developed technology will be used to treat wide-neck and fusiform aneurysms, as well as other types of clinical situations that currently are not adequately treated with either surgical or endovascular techniques."
Stern declined to review specifics about the deal, but did say that, "We will make an up-front licensing payment and payments based on certain milestones such as European CE mark and FDA clearance. Flexible Stenting Solutions will earn a royalty on everything we sell."
Stern declined to project a development timeline other than to say the platform is already developed and now must be optimized.
Lynn Yoffee, 770-361-4789; email@example.com