Clot Removal. Simplified.

Mechanical #thrombectomy is a standard endovascular procedure for treating a wide range of vascular occlusions (brain, heart, peripheral), often using mechanisms of action such as aspiration, stent triers / #draggingmetal, clot maceration, or compliant balloon sweeping, to name a few.

Stent retrievers are self-expanding, rigid, metallic stents deployed across a clot, then dragged and retracted to remove the thrombus. While dragging metal across vessels can be effective at recanalization, these tools often cause significant vessel damage due to the mechanical forces on delicate, thin-walled arteries.  Scarring, irritation, dissection, tissue necrosis are all issues in the intima (innermost layer) as well as the media (middle layer) >>>> triggering inflammation, endothelial dysfunction, wall thickening, rethrombosis, vessel dissections, and longer-term complications like post-thrombotic syndrome (venous #PTS) or stenosis (arterial scars).  

Primary Challenges with #draggingmetal: 

1. Vessel Scars and Tears: Metal outward expansion scraps or tears the endothelium, especially with mismatched sizes (non-compliant) or anatomical diameter changes.  CAD studies demonstrated intimal/medial wall thickening within 1 week of metal-dragging thrombectomy in ~20% of all cases.  This is likely under-reported due to challenges in human histological reviews in living patients.  Furthermore, stent retrievers cause greater vessel injury, which promotes more bleeding (hemorrhagic complications).
2. Distal #Embolization: Peripheral and Stroke studies continue to show 8-12% embolization rates using metal-dragging tools like stent retrievers.  These fragments dislodge and often travel to smaller branches, causing secondary occlusions. 
3. Vasospasm: Endothelial irritation from aggressive metal contact (stents, stent triers, and other thrombogenic tools) causes arterial narrowing, reduced blood flow, and potential ischemia.  In stroke studies, vasospasm occurred in 41.4% AFTER using a metal-dragging tool across the vessels. 
4. Perforation and Dissection: Metal edges and retraction forces can cause vessel perforation and dissection.  Metal dragging registry data demonstrates a 1.7% dissection rate, a 1% perforation rate, which is associated with a 20-30% mortality rate if symptomatic.  The pull forces with rigid metal cages are exponentially greater in a curved vessel (no compliance), which causes significantly more shear stress, over-expansion, and/or more force in smaller vessels.  
5. Failure Mode Challenges: Old, hard embolic material inside a metal dragging cage can cause retrieval issues that often lead to unnecessary surgical arteriotomy.  The failure mode to manage this potential issue remains an issue for metal scraping cages when embolic materials jam up a tool.  

What can we do?  

1. Develop drugs to treat the damage caused by dragging metal recanalization tools.  (Neuroprotectants, anti-inflammatories, high-dose atorvastatin for endothelial stabilization, etc.)
2. Develop thrombectomy tools (proven mechanisms of action) to remove acute and organized clots effectively, avoid metal-dragging complications, and address the distal embolization and blood loss issues associated with current thrombectomy options. 

While pre-clinical testing various mechanisms of action (metal-dragging stent triavers, Archimedes screws, aspiration vacuums, maceration technologies), ALL using the Fogarty balloon as the predicate device, iCHOR founders had their ah-ha moment in Minneapolis, MN.  Few technologies proved better efficacy than the surgical Fogarty; even fewer could show superiority regarding vessel integrity. In fact, many MoAs destroyed and dissected vessels.   “Can’t we just make the balloon sweep an endovascular tool for the thrombectomy toolbox.  A packaged system that can safely, effectively, and elegantly treat a wide range of morphology and anatomy with a single device,” Tim Blair, CEO 

• Every Vascular Surgeon has thought about the concept.    –

The Surgical Embolectomy Balloon Catheter was invented by Thomas J. Fogarty in 1959 while working in Cincinnati, OH, as a scrub tech for Dr Jack Cranley (#VascularSurgeon pioneer at Good Samaritan Hospital).

Dr Cranley challenged Fogarty to come up with a better method for removing clots than the standard open procedures of the time, many of which ended up as amputations.  

The 1st Fogarty Balloon Catheter was used in peripheral arteries in the early 1960s, using latex glove parts (pinky finger of the glove) bonded to the catheter and inserted surgically with a smaller cut down.  

The Fogarty Balloon Catheter was eventually patented 10 years later in 1969; however, most surgeons regarded the invention as “overly simple”, “lacks any proven credibility”, “the surgery is too small … the bigger the incision, the better the surgeon”.

Dr Thomas Fogarty continued to hand-make these tools and share them with his colleagues during residency and surgical training.  Through physician relationships, Fogarty eventually hooked up with Lowell Edwards (engineer in Irvine, CA) to fine-tune and manufacture the product.  Edwards Lifesciences continued to manufacture the Fogarty Balloon 50 years later. 

The Fogarty Balloon invention is arguably the most valuable surgical tool for vascular surgeons in treating vascular #clots (fresh to adherent clot).  It’s a surgical procedure driven by simplicity, a predictable mechanism of action, and a consistent result.

#iCHORVascular: “A system that can get the job done across a wide range of vascular issues with the least amount of effort and the least amount of cost.” Dr Troy Long, VIR and Co-Founder

Thrombolytic therapy (Lytics) is used to dissolve blood clots in peripheral vascular conditions, such as deep vein thrombosis (DVT) or peripheral arterial occlusion. While effective in patients who qualify, drug therapy carries significant risks and challenges. Below are the key problems associated with lytic drug therapy for peripheral vascular clots:

-BLEEDING RISKS: 

Lytics (e.g., tissue plasminogen activator [tPA], streptokinase) increase the risk of major bleeding, including intracranial hemorrhage, gastrointestinal bleeding, or bleeding at the catheter site. This is the most serious complication, with studies reporting major bleeding rates of 5-12% in peripheral thrombolysis.  Many patients with peripheral vascular clots have contraindications to lytic therapy, such as recent surgery, active bleeding, prior stroke, allergic reactions, or uncontrolled hypertension. This limits lytic therapy in a significant portion of patients, with some studies showing as much as 60% of patients being contraindicated for lytics.

-ICU LENGTH-OF-STAY (LOS) COSTS & COMPLICATIONS:                 Lytic therapy requires close monitoring or a specialized unit due to these bleeding risks, which are associated with extended infusion times (hours to days), frequent imaging, and laboratory assessments (e.g., fibrinogen levels, clotting parameters).  Beyond the risks, lab/nursing resources, and patient discomfort associated with overnight lytic therapy, the drug cost adds $2000 to $10,000 / day, with ICU occupancy costs between $20,000 to $50,000 / day. 

-LIMITED EFFICACY IN CHRONIC OR AGED CLOTS:

Lytic therapy is most effective for acute clots (less than 14 days old). Chronic clots, which are more organized and fibrotic, are less responsive, leading to incomplete clot dissolution and persistent vascular occlusion.

-CATHETER DIRECTED THROMBOLYSIS (CDT) COMPLICATIONS:

CDT, often used for targeted delivery, requires invasive catheter placement, which can cause vessel injury, infection, or hematoma. Prolonged infusion (12-72 hours) increases these risks and requires intensive monitoring in the ICU. 

-POST THROMBOTIC SYNDROME (PTS):

Even with successful clot lysis, patients may develop PTS, characterized by chronic pain, swelling, and ulceration due to venous damage. Lytic therapy reduces PTS risk compared to anticoagulation alone but does not eliminate it. Even after successful thrombolysis, re-occlusion can occur if underlying vascular issues (e.g., stenosis, endothelial dysfunction) are not addressed. Adjunctive treatments like stenting or anticoagulation are often needed but may not fully prevent recurrence.

WHAT CAN WE DO?

• Seek mechanical thrombectomy solutions to eliminate or reduce the bleeding risks and ICU costs associated with lytics.
• Seek mechanical thrombectomy therapies that avoid lytics or surgery, and therefore allow patients to get on their anti-coagulation therapies sooner to prevent re-occlusion.
• Seek mechanical thrombectomy therapies that eliminate blood loss, reduce vessel damage, and reduce hospital LOS.
• Combining thrombolysis with mechanical thrombectomy for faster clot removal.
• Regular monitoring of fibrinogen levels and clinical signs of bleeding.
• Careful patient selection to minimize bleeding risks if using lytics.

Ease of use, Safe, Effective, Efficient

When we (collective we) create solutions to solve today’s healthcare challenges, unmet needs are mostly driven by the end users.  End users like physicians, nurses, techs, or administration help marketing teams, entrepreneurs, and engineering teams understand the problems and it’s up to those individuals to create and fund solutions.

Generic development process for solving a problem in healthcare:

• Identify the unmet need / potential solutions (marketing leads)
• What is the business case / opportunity (marketing)
• Identify the “must haves” for the engineers (marketing starts to take a back seat)
• Develop the highly engineered solution (regulatory / engineering push marketing into the trunk, sales is completely unaware, physicians utilized in controlled scenarios)
• 16 to 36 months to create solutions for regulatory clearance
• Use the first product in the real world (sales and marketing take ownership)
• Marketing now driving to realize everything was way over engineered for real world utility (voice of customer work AFTER everything is built)
• To hit targets, sales at every case to make sure every stakeholder understands the twist triggers, levers, buttons, and locks are all connected to blue tooth with an Ai machine the spits out data that has no impact on outcomes or decision making – but it is super cool!
• Sales teams are bogged down in trouble shooting, changes are taking too long
• Engineers then call salespeople “jock-ular idiots who don’t understand regulated processes” while sales calls their engineering counterpoints “worthless nerds who need to get out in the field”.  

The finger pointing begins, ahhhhh #medtechinnovation!

For every (1) in healthcare who says this never happens, we can find (20) who will say this always happens and live it today.  Here is an example of the problem loop when we over engineer solutions:

• We increase the cost of sales (a hit to company margins)
• We lose sales opportunities in other areas (a hit to top line revenue)
• We increase adverse events: reps working hard to reduce in-field mistakes
• We deploy clinical / regulatory resources to adjudicate / remediate growing field issues (a hit to operating costs)
• We create new solutions to fix the shortcomings, i.e. blood return systems for devices that create massive blood loss
• Highly engineered products in healthcare often come with high manufacturing scrap rates (drives up cost or drives down margins or both)
• We in turn drive up the costs to the hospital to compensate (health economics)

What can we do? 

• Aim for simplicity, ease of use that can make an end users job easier will ALWAYS trump price and cool tech
• Aim for simplicity that does not require a rep or a clinical for a good result
• Simplicity will reduce adverse events / potential for device harm- #occams razor will drive down adverse events
• Simplicity will improve manufacturing reliability and optimize margins 
• Aim for simplicity that optimizes workflows (being disruptive can be highly problematic, be disruptive by democratizing solutions anyone can use)

Mechanical #thrombectomy is a standard endovascular procedure for treating a wide range of vascular occlusions (brain, heart, peripheral), often using mechanisms of action such as aspiration, stent retrievers, maceration, or compliant sweeping balloons, to name a few.

Most patients with #peripheralvascularocclusions (acute or organized) are dealing with comorbidities, suggesting that unhealthy #peripheralvascular diseased limbs are often attached to other patient issues such as cancer, anemia, diabetes, coronary artery disease, drug use, trauma, bleeding disorders, etc. 

Thrombectomy studies report on the amount of blood loss because it is a big deal in surgical and endovascular therapies.  This becomes more evident in peripheral disease, where clot segments are lengthy and often heavily organized, leading to heavier blood loss, especially for compromised patients.  Aspiration sales teams have memorized responses for a 300mL blood loss – “meh, it’s not a big deal ……..”.  Acute Bloss loss can be a big deal for sick patients!  A 200-300mL (4-6% of volume) hemodynamic loss can cause a decrease in blood pressure and an increase in heart rate (compensatory tachycardia) as the body works to maintain cardiac output.  A perfectly healthy patient might tolerate this acute blood loss, but those with comorbidities may experience increased heart strain, triggering ischemia, and unfortunately, most patients dealing with #clot issues are usually dealing with other issues as well. 

• Patients with #CAD are particularly vulnerable to drops in oxygenation (ischemia).  Even a small blood loss can exacerbate ischemia. 
• Patients with kidney issues are equally vulnerable to blood loss.  Mild blood loss reduces renal blood flow and increases blood glucose levels, which is a concern for patients with kidney disease and diabetics, as it likely worsens kidney function that is already compromised.  

What do we do to avoid blood loss during #thrombectomy procedures?  

• Seek #endovasculartools over surgical options to avoid surgical and blood loss complications. 
• Seek endovascular tools with mechanisms that don’t rely on removing blood, period!  And do not aspirate the blood, then push the blood back into the patient (causing hemolysis).  Blood saving during a thrombectomy is a solution designed to treat engineering shortcomings.
• Seek therapeutic choices that eliminate blood loss.