Arsenal Medical, a medtech firm primarily based in Massachusetts, has developed Neocast, an embolic biomaterial designed for catheter-mediated embolization procedures. Standard supplies for embolization can have a number of limitations, together with an absence of radiopacity, catheter clogging, catheter entrapment on the supply web site, solvent-mediated ache on the supply web site, they usually may even trigger sparking of electrocautery instruments.
Neocast is solvent-free, avoiding supply web site ache, and features with a novel shear-thinning motion that enables deep vessel penetration. The fabric flows with the blood to embolize distal vessels first, offering extra full embolization. Neocast has additionally been created to be non-adhesive to catheters, decreasing the probabilities of blockage, and may be delivered utilizing commonplace microcatheters.
Medgadget had the chance to talk with Upma Sharma, President and CEO of Arsenal Medical, concerning the expertise.
Conn Hastings, Medgadget: Please give us an summary of the applying of embolic merchandise, together with how and when they’re used.
Upma Sharma, Arsenal Medical: Embolization is a non-invasive process used to dam blood circulate of a goal vessel. There are a variety of medical functions all through the physique for embolization together with devascularizing tumors, stopping bleeding, remedy of aneurysms, and new functions are regularly being explored. Usually, a catheter is inserted by means of both a puncture within the groin (femoral artery) or wrist (radial artery) and tracked to the goal vessel the place the embolic product is delivered or injected. The embolic product chosen will depend on the wants of the precise situation being handled and may be broadly segmented into two classes: proximal embolization which occludes circulate near the catheter tip (the place merchandise similar to coils and plugs are used) and distal embolization the place penetration deeper into the vascular mattress is desired (the place particles and liquid embolics are sometimes used).
Medgadget: What are the restrictions with current embolic options?
Upma Sharma: Particles and liquid embolics have historically been used to attain penetration and occlusion of the microvasculature. Particles aren’t radiopaque making imaging throughout injection troublesome and have been identified to trigger catheter clogging. Legacy liquid embolics have been available on the market for over 20 years and have identified limitations together with inconsistent consumer expertise, untimely reflux, and catheter entrapment attributable to adhesion. The market’s present main liquid embolic incorporates a solvent, dimethyl sulfoxide (DMSO), which may trigger ache upon injection, necessitating using anesthesia and particular suitable catheters. Different limitations embody lowered visibility upon imaging attributable to artifacts, and the danger of sparking with electrocautery instruments throughout surgical procedures. NeoCast was purpose-built to offer deep penetration, whereas addressing the restrictions of current merchandise.
Medgadget: Please give us an summary of Neocast, and the way it’s supposed for use.
Upma Sharma: NeoCast is a solvent-free biomaterial that makes use of shear thinning science to allow deep penetration into goal vessels within the mind whereas minimizing the danger of non-target embolization. Its distinctive materials traits present enhanced management throughout injection and constant efficiency throughout customers. NeoCast is radiopaque, MR-safe, non-adhesive, and suitable with many commonplace microcatheters. NeoCast’s promising traits are anticipated to have utility throughout extra neurovascular functions the place deep vessel penetration is desired, together with the remedy of continual subdural hematoma (cSDH) and hypervascular spinal tumors. The on-going medical trial for NeoCast is concentrated on preoperative embolization of hypervascular mind tumors, similar to meningiomas. Hypervascular mind tumors are liable to extreme bleeding throughout surgical elimination, which may result in problems, obstruction of the surgical area, and will end in longer process instances. Preoperative embolization occludes blood circulate to the tumor mattress and can lead to lowered blood loss throughout surgical procedure. Latest research have additionally demonstrated a profit in recurrence-free survival after pre-operative embolization.
Medgadget: How does Neocast differ from pre-existing embolic applied sciences? What are its benefits?
Upma Sharma: NeoCast is a purpose-built embolic biomaterial that’s differentiated from present merchandise available on the market. Particularly, NeoCast makes use of shear-thinning science to attain a fabric that travels with the blood circulate to fill and “casts” essentially the most distal vasculature first. This supplies the consumer with enhanced management for a extra full occlusion and minimizes the danger of untimely reflux. Moreover, NeoCast is solvent-free which eliminates considerations associated to using a solvent requiring administration of affected person ache (similar to basic anesthesia) and catheter compatibility.
Medgadget: Does the fabric require a specialised supply system? How is it delivered, and the way do you stop system blockage?
Upma Sharma: NeoCast has been engineered to be non-adhesive to catheters and may be delivered utilizing commonplace microcatheters, with no specialised system.
Medgadget: What different biomaterial applied sciences have you ever developed and the way do they work?
Upma Sharma: Arsenal was based with the broad imaginative and prescient of remodeling medical units with supplies. Along with NeoCast, we’re additionally at the moment growing ResQFoam, a foam designed to quickly develop all through the stomach to attain management of intra-abdominal hemorrhage (think about a human fix-a-flat). It’s a probably life-saving intervention that may quickly stabilize a affected person and function a bridge to definitive surgical procedure for sufferers. Designated by FDA as a Breakthrough Machine, ResQFoam creates conformal contact and applies stress to an actively bleeding web site inside the physique. It consists of two liquids that, when mixed and injected into the stomach utilizing the ResQFoam supply system, fill the stomach cavity to regulate bleeding and create a solidified foam forged that covers the stomach organs. The security, effectiveness, and benefit-risk profile of ResQFoam are at the moment being evaluated in an IDE-approved examine.
Arsenal is at the moment targeted on advancing NeoCast and ResQFoam in the direction of commercialization, whereas we are also exploring alternatives in peripheral embolization and ladies’s well being.
Hyperlink: Arsenal Medical homepage…