BME100 f2017:Group7 W1030 L1

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OUR TEAM

Sarah Brady
River Rodriquez
Kayla Culhane
Adriane Cana
Sevy Perez

LAB 1 WRITE-UP

Health Care Issue

Cardiovascular disease (Coronary Artery Disease) is a result of plaque that builds up in coronary arteries. According to Mayo Clinic (2017), this plaque damages the heart and blood vessels by creating stiffness and a blockage-inducing lining. Blockage prevents the oxygenated blood flow that normally maintains human organs and tissue (Mayo Clinic, 2017). Lifestyle indicators such as obesity, failure to regularly exercise, eating poor diets that lead to ‘bad’ cholesterol, and smoking are primary causes of plaque buildup (Mayo Clinic, 2017). Unfortunately, the first symptoms that indicate cardiovascular disease are usually a heart attack or a stroke (Mayo Clinic, 2017).

Coronary arteries wrap around the outside of the heart and are very important to the overall health of the body because they provide necessary blood flow and oxygen to the heart muscle (Johns Hopkins Medicine, n.d.). Plaque buildup (atherosclerosis) results in narrowing of the artery and abnormal blood flow, while hardening or rupturing of plaque are the primary dangers related to plaque buildup because they can lead to narrowing of the artery and blood clots respectively (National Heart, Blood, and Lung Institute, 2016). Lack of blood flow to the heart causes parts of the heart to die (National Heart, Blood, and Lung Institute, 2016). According to Stefanadis, Antoniou, Tsiachris, and Peitri (2017), plaque buildup occurs generally more readily in particularly susceptible areas of veins, such as in bends, and is usually dependant on lipid buildup. The final part of the plaque accumulation process is when mineralization occurs, which is triggered by inflammation from plaque buildup (Stefanadis, et al., 2017). Cholesterol is moved through the veins by lipoproteins (American Heart Association, 2017b).

One of the main problems when discussing the buildup of plaque is to explain HDL particles and LDL particles that are in the blood. Harvard Health Publications (2014) explained that HDL particles are “good cholesterol” that “flow through the blood and pick up LDL particles (bad cholesterol).” Clinical trials for the drug torcetrapib were designed to increase HDL particles, but these ended when researchers learned that the connection between high HDL and decreased cholesterol or plaque build up is not significant (Harvard Health Publications, 2014). Successful reduction of plaque build up seems to come down to the combination of decreased LDL particles with a proper amount of HDL particles (Harvard Health Publications, 2014).

The age demographic that tends to suffer from cardiovascular disease is adults over the age of 55 (National Heart, Blood, and Lung Institute, 2014). This trend occurs because of less blood vessel flexibility, more plaque buildup, and less physical activity (National Heart, Blood, and Lung Institute, 2014). These factors, when combined, can lead to a tenfold increase in the possibility of someone developing Cardiovascular Heart Disease (National Heart, Blood, and Lung Institute, 2014). Heart disease has wide-ranging impacts worldwide on the quality of health in aging populations. The American Heart Association (2017a) compiled updated statistics on the incidence of heart disease that claim cardiovascular disease results in about 801,000 deaths per year in the US and 2,200 death in the US daily. They also found that 92.1 million Americans have cardiovascular disease and that it is the cause of 31% of all deaths across the world (American Heart Association, 2017a). The latter number is expected to hover at around 23.6 million in the year 2030 (American Heart Association, 2017a).

One of the surgical methods used to relieve the fatal effects of cardiovascular disease is angioplasty. Angioplasty involves placing a catheter into an artery (American Heart Association, 2015). X-Rays or cameras are used to view the blockage, while plaque is pushed out of the way to improve blood flow with a balloon that inflates on the catheter (American Heart Association, 2015). Though this procedure is relatively safe because anesthesia isn’t needed, there is a large chance that the results will not be permanent, especially considering no plaque is removed (American Heart Association, 2015). Methods to actually remove the plaque permanently are few and far in between.

Our atherectomy ‘toothbrush for the vein’ would improve on angioplasty rotary plaque removal tools by preventing abrasions to the arterial wall and breaking up plaque while using cheaper materials. The device is formed from a flexible metal inner ‘tube’ shape with different platforms, surrounded by a disposable gel tip that protects the vein from damage, significantly decreasing the instance of restenosis.

Customer Validation

Physicians

  1. IMS Cardiology Kevin Berman MD
    • Address: 6036 N 19th Ave #501, Phoenix, AZ 85015
    • Phone: (623) 433-0202
  2. Cardiovascular Consultants Ltd: Tran Andy H MD
    • Address: 3805 E Bell Rd # 3100, Phoenix, AZ 85032
    • Phone: (602) 494-3656
  3. Dr. Richard R Heuser
    • Address: 555 N 18th St, Phoenix, AZ 85006
    • Phone: (602) 234-0004
  4. Phoenix Cardiac Surgery: Fang H K MD
    • Address: 3131 E Clarendon Ave # 102, Phoenix, AZ 85016
    • Phone: (602) 253-9168

Providers

  1. Tempe St. Luke’s Medical Center
    • Address: 1500 S. Mill Avenue, Tempe, AZ 85281
    • Phone: (602)-251-8589 (Media), (480) 784-5500 (Switchboard)
  2. St. Joseph's Vascular Clinic
    • Address: 7171 S 51st Ave, Laveen Village, AZ 85339
    • Phone: (602)-406-7564
  3. Phoenix Children's Hospital
    • Address: 1919 E Thomas Rd, Phoenix, AZ 85016
    • Phone: (602) 933-1000
  4. Select Specialty Hospital - Phoenix Downtown
    • Address: 1012 East Wiletta, 4th Floor, Phoenix, AZ 85006
    • Phone: (602) 839-6550
  5. Mayo Clinic - Phoenix
    • Address: 5777 E Mayo Blvd, Phoenix, AZ 85054
    • Phone: (480) 342-2000
  6. Banner Good Samaritan Health Center
    • Address: 1111 E McDowell Rd, Phoenix, AZ 85006
    • Phone: (602) 839-2000
  7. Dignity Health St. Joseph’s Hospital and Medical Center
    • Address: 350 W Thomas Rd, Phoenix, AZ 85013
    • Phone: (602) 406-3000
  8. Banner Boswell Medical Center
    • Address: 10401 W Thunderbird Blvd, Sun City, AZ 85351
    • Phone: (623) 832-4000

Payers

  1. Aetna
    • Address: 4645 E Cotton Center Blvd, Phoenix, AZ 85040
    • Phone: (800)-225-3375
  2. Freeway Insurance Services
    • Address: 805 W. Baseline Rd , Ste 4, Tempe, AZ, 85283
    • Phone: (602)-714-1869
  3. Ayala Insurance Services
    • Address: 2747 W Southern Ave, Tempe, AZ 85282
    • Phone: (480)-736-2885
  4. Arizona Health Insurance Experts
    • Address: 3800 N Central Ave, Phoenix, AZ 85012
    • Phone: (480)-725-7484

Purchasers

  1. C.R. Bard, Inc.
    • Address: 1625 W 3rd St, Tempe, AZ 85281
    • Phone: (480) 303-2600
  2. New Amsterdam Sciences
    • Address: 14358 N. Frank Lloyd Wright Blvd., Suite 3
    • Phone: (480)-477-7735
  3. Radiant Research
    • Address: 2141 E. Broadway Road Suite 120 Tempe, AZ 85282
    • Phone: (480)-820-5656
  4. Redpoint Research
    • Address: 11065 N. 19th Ave., Phoenix, AZ 85029
    • Phone: (602) 395-1200

Competitors

Current Solutions Advantages Disadvantages Why Our Device Is More Marketable
Balloon Angioplasty According to Medtronic (2016), the main advantages are reducing narrowness of arteries, improving blood flow, hardly any complications, and

the ability for patients to return to normal fairly quickly. Also, it's done under local anesthesia, which is less risky (Medtronic, 2016).

Unmet Financial Needs:

Generally, this procedure is less expensive than atherectomy, but still incurs significant cost for physicians (Guzman, et al., 1994).

Unmet Safety Needs:

Can cause infection to insertion site, lead to restenosis, or tear/create a hole in the artery (Medtronic, 2016).

Our device is made out of material that will give way to the blood and cause minimal arterial blockage. This will make our device safer and thus a more appealing option.
Stent Implantation The primary advantage is that stents are inserted through a minimally invasive procedure (Healthline, 2017). New stent technology may also be trending toward a bioabsorbable material that wouldn't leave behind a foreign object and would solve many of the problems related to stents (Cleveland Clinic, 2013). Unmet Financial Needs:

According to Peterson et al. (1999), "the mean in-hospital cost for stent patients was $3,268 higher than for those receiving coronary angioplasty." But Peterson et. al (1999) also noted that "stent patients were less likely to be rehospitalized." This leads to the conclusion that the tradeoff for a stent is higher cost for decreased hospital time and increased safety.

Unmet Technological Needs:

A bioabsorbable material that doesn't cause narrowing, bleeding, or restenosis (Cleveland Clinic, 2013).

Unmet Safety Needs:

Patient may have an allergic reaction to the stent, blood vessels can narrow again, the stent can cause bleeding, and scar tissue may require a second procedure (Seconds Count, 2014). Directional atherectomy resolves some of these problems.

Our device will not cause any bleeding. Stents cause blockage of the blood whereas our device would be made of flexible material allowing for the movement of blood through it. Metal stents are also very rigid which reduces blood vessels’ ability to expand. Ease of use with our device will make it more profitable and safe.
Rotational Atherectomy (Rotoblator) According to Akkus, Abdulbaki, Jimenez, and Tandon (2015), the Rotoblator is capable of cutting different types of diseased tissue, such as calcium, fibrous tissue, fatty deposits, and restenotic tissue. It also creates very small plaque debris (98% smaller than 10 micrometers), which means that the immune system can clear it more easily (Akkus, et al., 2015). Unmet Financial Needs:

According to Guzman, Simpfendorfer, Fix, Franco, and Whitlow (1994), Atherectomy can increase the cost of supplies from traditional angioplasty by 79%. In total, it can increase the cost of the procedure by about 28% (Guzman, et al., 1994).

Unmet Technological Needs:

Does not prevent restenosis and is primarily used to prepare vessels for a stent (Akkus, et al., 2015). This means it doesn’t eliminate the need for a stent.

Unmet Safety Needs:

It has many contraindications on a small scale, but the most significant (found at 8.9%) occurrence was non-Q MI (Akkus, et al., 2015). Essentially, it increases risk of heart attack.

We will reduce cost by decreasing the energy requirement for the device and relying on cheaper materials. Doctors can decrease how much it costs them to perform the procedure and produce a larger profit.
Directional Atherectomy (SilverHawk/TurboHawk plaque excision systems) According to Medtronic (2017a), the primary advantages are the ability to adjust direction, the maximization of lumen gain, and the minimization of barotrauma while removing plaque from blocked arteries. The patency statistics are also very good, with a 12-month patency of 78%, as well as a limb salvage rate of 95% (Medtronic, 2017c). The patency is similar to the patency of stent procedures, but it doesn't leave an implant behind and it leaves options open for future treatment while requiring minimal set up time and not stretching the vessel (Medtronic, 2017c). There are also two different cutter types that can be used for all plaque morphologies (Medtronic, 2017c). Additional advantages include approximately equal patency in both diabetic and non-diabetic patients (Medtronic, 2017d) and the effectiveness of the device for treating patients with critical limb ischemia (Akkus, et al., 2015). One study found the procedure success rate was as high as 97.6% (Akkus, et al., 2015). Unmet Financial Needs:

As mentioned above, atherectomy devices increase the cost of supplies significantly from traditional balloon angioplasty.

Unmet Technological Needs:

SilverHawk/TurboHawk are only designed for atherectomy of the peripheral vasculature (Medtronic, 2017b). Though they are effective in limiting damage to arterial walls, they are not designed to remove plaque in the coronary, carotid, iliac, or renal vasculature (Medtronic, 2017b).

Unmet Safety Needs:

Also, Akkus, et al. (2015) found that directional atherectomy doesn't necessarily make it easier to direct plaque excision in all cases and can cause pseudoaneurysm formation, no flow, and ischemia.

Our product is designed to work in all veins of the body. The application is thus far wider for patients suffering from plaque buildup in many types of veins, meaning the doctor then doesn’t need to invest in multiple different atherectomy devices. Cost and multi-usage are opportunities for maximizing benefit to physicians over Medtronic's products.
Pathway Jetstream PV Atherectomy System Like Directional Atherectomy, Pathway Jetstream increases luminal gain and removes diseased tissue with minimal damage to the vessel wall (Akkus, et al., 2015). On the other hand, it is more versatile in that the same catheter can be used for both thrombectomy and RA, plus it is the only atherectomy device that continuously aspirates and actively removes plaque and blood clots (Akkus, et al., 2015). Unmet Financial Needs:

As mentioned previously, atherectomy devices increase the cost of supplies significantly from traditional balloon angioplasty. The single use catheter might be a design limitation which requires greater material cost (Akkus, et al., 2015).

Unmet Technological Needs:

Needs to be used in conjunction with embolization protection, which means the technology is not an end or true solution in and of itself (Akkus, et al., 2015).

Unmet Safety Needs:

One study found the 1-year restenosis rate to be 38.2% (Akkus, et al., 2015). Abrupt vessel occlusion, dissection, distal emboli, hematoma at access site, infection, perforation, pseudoaneurysm, renal failure, restenosis, and thrombus formation are some of the reported complications of Jetstream atherectomy (Akkus, et al., 2015).

We aim to completely eliminate damage to the vessel wall during atherectomy procedures.

We will also improve restenosis rate. If we avoid injury to the arterial wall, restenosis will be much less likely to occur, and then stent procedures will not be needed.

Additionally, our design will not require electricity, thus it has wider application across the world in nations where there is limited access to healthcare but coronary artery disease is still a leading cause of death.

Excimer Laser Atherectomy The light beam vaporizes plaque without damage to surrounding tissue and be used in both coronary and peripheral applications (directional can only be used in periphery) (Akkus, et al., 2015). Unmet Financial Needs:

As mentioned previously, atherectomy devices increase the cost of supplies significantly from traditional balloon angioplasty.

Unmet Technological Needs:

Adsorption depth is determined by both the light wavelength and the tissue, a factor that limits the effectiveness of the device in certain patients (Akkus, et al., 2015). Also, saline flushes have to be used before and after placement of laser catheter (Akkus, et al., 2015).

The properties of diseased tissue change the viability of this option. Our device’s success rate is not dependent on the depth of the tissue, nor are saline flushes required.
Orbital Atherectomy Similar to rotoblator design, but does not obstruct flow in a diseased vessel (Akkus, et al., 2015). Unmet Financial Needs:

As mentioned previously, atherectomy devices increase the cost of supplies significantly from traditional balloon angioplasty.

Unmet Technological Needs:

Plaque removal with orbital atherectomy is effective for severely calcified lesions, but not as effective for soft plaque, which can be just as negative to health in some cases (Akkus, et al., 2015). Also, orbital atherectomy places more emphasis on plaque modification and less on luminal gain (Akkus, et al., 2015).

Our device covers the three primary bases of successful atherectomy: (1) increased luminal gain, (2) modification of soft and calcified plaque, and (3) little to no restenosis or MI post-treatment. These three factors fill in the gaps that show up in all aforementioned atherectomy devices.

IP Position

Number/ Assignee Title Summary Image Filing date/ Status
US20160192962A1/Avinger Inc Atherectomy catheters devices having multi-channel bushings Atherectomy catheters that include a bushing configured to be hinged off-axis and include two overlapping channels through which a central cutter and/or rotating driver may move. The multi-channel bushing allows reliable and low-force displacement of a distal tip to expose a cutter. Link to image: https://patents.google.com/patent/US20160192962A1/en 2016-03-16/Granted
US20160262839A1/Avinger Inc Occlusion-crossing devices, atherectomy devices, and imaging Identifying atherectomy plaque mass within a vessel by imaging and radial force application. Link to image: https://patents.google.com/patent/US20160262839A1/en 2016-05-23/Pending
US9439674B2/Cardiovascular Systems Inc Rotational atherectomy device with exchangeable drive shaft and meshing gears A rotational atherectomy device that uses an exchangeable drive shaft, a gear at a distal end for meshing engagement, and a prime mover gear on the output shaft of the prime mover. Link to image: https://patents.google.com/patent/US9439674B2/en 2014-07-24/Active, expires 2035-03-26
US20160262791A1/Avinger Inc Atherectomy catheters with longitudinally displaceable drive shafts Longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. Include imaging sensors that can rotate. Link to image: https://patents.google.com/patent/US20160262791A1/en 2016-05-23/Pending
US20160183967A1/Rex Medical LP Artherectomy device

Atherectomy device used to remove deposits of plaque using an axially fixed outer member and a rotatable shaft. Fixed on the shaft is a rotatable tip. The rotatable shaft has a guidewire lumen for the reception of a guidewire insertion of the device.

Link to image: https://patents.google.com/patent/US20160183967A1/en 2015-11-20/Pending
US6379373B1/Incept LLC, Confluent Surgical Inc Methods and apparatus for intraluminal deposition of hydrogels Forming hydrogel systems in situ are provided using a delivery system configured to deliver two or more fluent prepolymer solutions without premature crosslinking. Link to image: https://patents.google.com/patent/US6379373B1/en 1999-09-03/Active
US20070282303A1/Spectranetics Corp Thrombectomy and soft debris removal device A device that removes material from a living being using an infusate pump and an aspiration pump, both powered by a motor. Link to image: https://patents.google.com/patent/US20070282303A1/en 2007-05-21/Granted
US20080306498A1/Cardiovascular Systems Inc Eccentric abrading head for high-speed rotational atherectomy devices A rotational atherectomy device with a flexible, elongated, rotatable drive shaft with at least one flexible eccentric enlarged abrading head. Link to image: https://patents.google.com/patent/US20080306498A1/en 2007-06-11/Granted
US20090069829A1/Cardio Flow Inc Rotational Atherectomy Device with Distal Protection Capability and Method of Use A rotational device for removing a stenotic lesion from within a vessel of a patient using a flexible hollow drive shaft. Link to image: https://patents.google.com/patent/US20090069829A1/en 2006-05-25/Granted
US6503261B1/Boston Scientific Scimed Inc Bi-directional atherectomy burr A bi-directional atherectomy device for removing deposits from a vessel. Link to image: https://patents.google.com/patent/US6503261B1/en 2001-01-17/Expired - Fee Related

Fundability Worksheet Scores

a. Customer Validation: 1

If we’re able to make the device cheaper by using cheaper products, then doctors and hospitals can significantly cut the cost of purchasing an atherectomy device, thereby making a higher profit on procedures. Improved safety and less occurrence of restenosis would benefit insurance companies and hospitals due to the decreased time spent within the hospital and less procedures necessary.

b. Competitors: 1

Crowded market with many competitors, but there are opportunities for better design that would decrease cost and improve safety. None of the products are a 'one stop' product. All have downsides that make none of them the perfect solution atherectomy device.

c. IP Position: 1

There are many patents, but there is also a lot of opportunity for development in the market as far as safer materials and design. The abundance of variety suggests that though there is a more competitive environment, there is still no supreme solution and the problem is large enough to accommodate further innovation.

References

Akkus, N. I., Abdulbaki, A., Jimenez, E., & Tandon, N. (2015). Atherectomy devices:

technology update. Medical Devices (Auckland, N.Z.), 8, 1–10. http://doi.org/10.2147/MDER.S50594

American Heart Association. (2017a). Heart Disease and Stroke Statistics 2017 At-a-Glance.

Retrieved from https://www.heart.org/idc/groups/ahamah-public/@wcm/@sop/@smd/documents/downloadable/ucm_491265.pdf

American Heart Association. (2017b). HDL (Good), LDL (Bad) Cholesterol and Triglycerides.

Retrieved from
http://www.heart.org/HEARTORG/Conditions/Cholesterol/HDLLDLTriglycerides/HDL-Good-LDL-Bad-Cholesterol-and-Triglycerides_UCM_305561_Article.jsp#.WadLm1PyuRt

American Heart Association. (2015). What Is Coronary Angioplasty? Retrieved from

https://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_300437.pdf

Cleveland Clinic. (2013). Researchers Study New Stent’s Pros, Cons. Retrieved from

https://health.clevelandclinic.org/2013/10/researchers-study-new-stents-pros-cons/

Guzman, L.A., Simpfendorfer, C., Fix, J., Franco, I., Whitlow, P.L. (1994). Comparison of costs

of new atherectomy devices and balloon angioplasty for coronary artery disease. The American Journal of Cardiology, 74, 22-25. http://dx.doi.org/10.1016/0002-9149(94)90485-5

Harvard Health Publications. (2014). Can we reduce vascular plaque buildup?. Retrieved from

https://www.health.harvard.edu/heart-health/can-we-reduce-vascular-plaque-buildup

Healthline. (2017). Cardiac Stent. Retrieved from

http://www.healthline.com/health/heart-disease/stent#overview1

Johns Hopkins Medicine. (n.d.). Anatomy and Function of the Coronary Arteries. Retrieved from

http://www.hopkinsmedicine.org/healthlibrary/conditions/cardiovascular_diseases/anatomy_and_function_of_the_coronary_arteries_85,P00196/

Mayo Clinic. (2017). Heart disease. Retrieved from

http://www.mayoclinic.org/diseases-conditions/heart-disease/symptoms-causes/dxc-20341558

Medtronic. (2016). Balloon Angioplasty. Retrieved from

http://www.medtronic.com/us-en/patients/treatments-therapies/pad-balloon-angioplasty/balloon-balloon-angioplasty.html

Medtronic. (2017a). Peripheral Therapies - SilverHawk Plaque Excision System. Retrieved from

http://www.peripheral.medtronicendovascular.com/us/product-type/directional-atherectomy/silver-hawk/overview/index.htm

Medtronic. (2017b). Peripheral Therapies - Important Safety Information TurboHawk Plaque

Excision System. Retrieved from http://www.peripheral.medtronicendovascular.com/us/product-type/important-safety-information/index.htm#turbohawk

Medtronic. (2017c). TurboHawk Plaque Excision System. Retrieved from

http://www.peripheral.medtronicendovascular.com/wcm/groups/mdtcom_sg/@mdt/@endov/documents/documents/da-turbohawk-br.pdf

Medtronic. (2017d). Clinical Trial Summary. Retrieved from

http://www.peripheral.medtronicendovascular.com/wcm/groups/mdtcom_sg/@mdt/@endov/documents/documents/da-definitive-le-cl.pdf

National Heart, Blood, and Lung Institute. (2014). Who is at Risk for Heart Disease? Retrieved

from https://www.nhlbi.nih.gov/health/health-topics/topics/hdw/atrisk

National Heart, Blood, and Lung Institute. (2016). What Is Coronary Heart Disease? Retrieved

from https://www.nhlbi.nih.gov/health/health-topics/topics/cad

Peterson, E.D., Cowper, P.A., DeLong, E.R., Zidar, J.P., Stack, R.S., Mark, D.B. (1999). Acute

and long-term cost implications of coronary stenting. Journal of the American College of Cardiology, 33, 1610-1618. DOI: 10.1016/S0735-1097(99)00051-0

Seconds Count. (2014). Understanding the Benefits & Risks of Angioplasty and Stenting.

Retrieved From http://www.secondscount.org/treatments/treatments-detail-2/benefits-risks-of-angioplasty-stenting#.Wa2xYlPyuRs

Stefanadis, C., Antoniou, C. K., Tsiachris, D., & Peitri, P. (2017). Coronary Atherosclerotic

Vulnerable Plaque: Current Perspectives. Journal of the American Heart Association, 6. https://doi.org/10.1161/JAHA.117.005543