The mechanical thrombectomy market is ready for a new technology to replace outdated methods. Devices currently in the market have been used for over a decade and fall short as they are prone to distal embolization, inefficient aspiration, and clogging.
Capture Vascular has developed and commercialized the MegaVac Mechanical Thrombectomy System (MegaVac System), a technology uniquely designed to remove thrombus and emboli throughout the peripheral and coronary vasculature. This innovative technology offers occlusion, centering, anchoring, removal of clot, and delivery of fluids in one simple, efficient, and effective device.
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How does the MegaVac Mechanical Thrombectomy System work?
The MegaVac System utilizes two components:
1. A novel vessel occluding funnel catheter (MegaVac catheter) which provides a large funnel mouth to receive the clot.
2. A wire based expandable clot retractor (ThromboWire) to retract the clot to the large mouth funnel of the MegaVac and to pull the clot into and through the shaft of the catheter while aspiration is being provided to the MegaVac.
The funnel of the MegaVac occludes blood flow with the patient’s own blood pressure using SafeSeal Technology to create a static environment which inhibits distal migration of thrombus, embolus, and other debris, and at the same time centering and anchoring the catheter. This method of two components working synchronously and in concert can be easily understood by viewing the video at www.capturevascular.com.
Why is it important to ensure complete clot removal?
In general, complete clot removal does a few things:
1. Eliminates the acute obstruction.
2. Minimizes or prevents distal embolization of residual thrombus that may occur at a later date or with subsequent treatment to the area (angioplasty, stenting, etc.).
3. Minimizes the subsequent formation of new thrombus on residual thrombus,
4. Provides for optimal stent apposition to the wall of the vessel vs. sandwiching residual thrombus between the stent and arterial wall which can be problematic subsequently.
5. Essentially restores the vessel to the condition prior to the thrombotic event.
What effect does your system have on non-thrombus arterial obstruction, like arterial calcifications?
The MegaVac catheter anchors and centers the distal catheter just proximal to an occlusion which more easily allows antegrade passage of crossing wires and other devices through the occlusion. Moreover, once the occlusion is navigated, therapeutic devices (atherectomy, drug coated balloons, etc) to treat the non-thrombotic occlusion may be passed through the MegaVac and utilized in a static environment that inhibits the distal migration of the liberated debris preventing distal arterial occlusion in the runoff vessels. Essentially, the MegaVac System allows the non-thrombotic occlusion to be navigated more easily and treated more safely.
What advantages does the MegaVac Mechanical Thrombectomy System offer over its competitors?
In thrombus removal, the MegaVac System provides several advantages:
- Vessel occlusion that minimizes or prevents distal embolization during the procedure.
- Anchoring of the distal MegaVac catheter that allows the operator to cross tight stenoses or tortuous vessel segments more easily.
- A large mouth funnel to receive the thrombus burden.
- The ThromboWire clot retractor to pull the thrombus into the large mouth funnel, to remove wall adherent clot, and to prevent catheter clogging by retracting the clot through the entire length of the catheter and into the aspiration syringe.
In non-thrombotic arterial occlusion, the MegaVac System provides a static work environment by occluding the vessel and minimizing distal migration of debris. It centers the distal catheter for more efficient antegrade passage of wires and tools, and anchors the distal catheter for more push ability of wires and tools. This allows the passage and utilization of therapeutic devices to treat the lesion while maintaining the proximal occlusion, and provides for the aspiration of any debris from the treatment prior to restoring flow.
Are the tools for removal of coronary artery thrombus different than the ones for peripheral artery thrombus?
Yes. Usually coronary artery thrombus is acute and rather soft. Most of this may be simply aspirated by the MegaVac. However, there may be a wall adherent clot that may not be removed by simple aspiration. Use of the ThromboWire removes this wall adherent clot that may prevent proper stent apposition to the arterial wall if not removed prospectively. Improper stent apposition has been implicated in in-stent restenosis, late stent thrombosis, and diminished outcomes amongst other untoward effects.
Moreover, minimizing distal embolization may be more important in the coronary arteries than in the peripheral vasculature. Distal embolization, when present, was associated with a 3X mortality in a subset analysis of the TOTAL Trial despite there being no difference in overall mortality with simple aspiration thrombectomy vs. no thrombectomy. With standard thrombectomy devices, distal embolization frequently occurs once flow has been restored. The MegaVac provides proximal occlusion during the entire thrombectomy procedure with aspiration of thrombus and debris to inhibit the distal embolization that may be very important to patient outcomes.
How have the TASTE and TOTAL Trials affected coronary thrombectomy and where does the MegaVac fit into that picture?
Both trials compared survival outcomes of performing routine thrombectomy with simple straw like aspiration catheters vs. no thrombectomy on all comers regardless if there was significant thrombus or not prior to angioplasty/stenting of patients presenting with STEMI. There was no survival difference between the two groups.
While the trials have been criticized on a number of fronts, the lack of any difference in mortality has caused a significant decrease in thrombectomy in STEMI cases. This expected reaction has bottomed and the use of thrombectomy in STEMI is now growing again, albeit the market is still smaller than prior to these studies.
Expanding on the answer in question 5, standard simple aspiration thrombectomy catheters, like those used in these two trials, frequently do not remove the majority of the clot. Once any flow is restored, most of the residual clot is simply washed off the wall and propelled downstream before it can be removed. Hence, the devices used in these two studies may be at least partially, if not mostly, responsible for the lack of differences between the two groups.
Because the MegaVac occludes flow prior to any aspiration, the aspiration efficiency is dramatically improved and thrombus and debris are not propelled downstream. Moreover, the ThromboWire may be used to remove wall adherent clots which, when present, prevent optimal stent apposition and may cause the resultant complications listed previously. Simply put, the MegaVac has the potential to remove more thrombus easier and more completely than current devices while preventing downstream embolization.
What interest in Capture Vascular have you had from physicians and industry?
Uniformly very positive. Physicians and KOL’s see the need for the device, understand the simple, intuitive concepts, perceive the potential benefits, and readily embrace the advances the MegaVac System offers. Many are eager to utilize it in their practice. Industry representatives also recognize the above positive benefits. They, understandably, wish to see market adoption before further substantive conversations.
How do you think syndicating an investment with angelMD will benefit Capture Vascular?
In addition to providing capital to pursue commercialization and the necessary market adoption that will further spur industry interest, syndicating with angelMD may provide a network of valuable resources to supply clinical feedback, perspectives, and information for the current intended and other not yet contemplated uses of the MegaVac System.
Tell us about your team and their unique capability in this specific field?
Capture Vascular has contracted with Telluride Medical Partners, (TMP) to provide management, development, marketing, accounting and other essential services necessary for an eventual successful exit. The TMP offer decades of experience in the development and commercialization of medical products. In addition to the TMP team, TMP has an advisory board with a vast knowledge of products, device commercialization, and M&A.
What is your current status on key company goals for the next 12 months?
Below is a sample of a few of Capture Vascular’s key initiatives for 2017:
- PAD product to market and expand adoption with strategic industry partners
and high volume offices.
- Design Freeze CAD devise and introduce 100 devices to market by Q-4 2017.
- Complete development of DVT device and conclude in vitro and in vivo testing.
- Issuance of CE mark for PAD device.
We are moving along per our plan on all three of these key initiatives:
- The PAD product is in the market.
- CE audit was done last month and issuance will be Aug 2017
- CAD prototypes were used in animal last week and the design functioned very well.
- Early stage DVT device was tested last week in lab and the results were positive allowing us to advance to a complete prototype.
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Image Credit: Capture Vascular