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Regaining Mobility is No Longer a Pipe Dream! Donald’s ArtAssist® Device Experience

Diana’s note: I’ve been digging around on the server lately for material I could use to add to this website. I came across two wonderful stories of patients whose lives were regained because they underwent ArtAssist® Device therapy. These people wished for their testimonials to be shared with others with the hope that anyone suffering from severe PAD would know that there’s one more hope before amputation.

Here is Donald’s letter to ACI Medical (identifying information has been omitted, but it is otherwise unabridged):

Email submission:

My wife and I rented the [ArtAssist® device] in June 2004. Between the time that we agreed to the rental, and the machine arriving at our home, I was placed in the hospital and subsequently had an amputation of the fourth toe on my right foot.

My first thank you is to the folks [at ACI] for their kindness and understanding, in adjusting the rental period, allowing me to get out of the hospital before starting the clock. The second thank you is for the extra cuffs that were provided to us when the original ones failed. Although you might not like to hear about your product failing, I was more than satisfied with the action we received from ACI.

Now, lets get to the real reason for my letter. In 2001, my blood flow in my lower legs was 62 in both legs. In 2004, that number dropped to 22 and 21, left and right respectively. Dr. ________ (my family doctor) had read about this apparatus [the ArtAssist® device] and suggested that I try the one he had gotten on loan from you. I did and as I mentioned above, then rented the device for three months and then purchased the machine.

I have been using this machine now for just over 6 months and had a Doppler test done last week. The results of which were beyond amazing. The normal number for a reasonably healthy individual is a percentage of blood pressure readings and would be 96 in both legs. My left leg is now 95, and my right leg is 91. Dr. ________ was as impressed as we were. I can’t begin to express my thanks for all you’ve done for me. I expect to be walking a golf course again this year. ONE YEAR AGO, I THOUGHT THAT WAS A PIPE DREAM!!!!!

Thank you again for all you’ve done, and I hope this letter will help convince others to at least try to turn back time.

Don, Ontario Canada

Stay tuned next week for another patient story of how an 83-year-old woman with foot pain and ulcers went from barely being able to put on a sock to taking walks around the block!

Aug 11, 2012 By acimedical ArtAssist®...The Arterial Assist Device®, PAD

Is funding cut a false saving? – The Irish Times – Tue, Jul 24, 2012

A home device that increases arterial blood flow to the leg can help save patients’ limbs – and taxpayers’ money – so why is it no longer paid for by some HSEs, asks MICHELLE MCDONAGH

EIGHTY SEVEN-year-old Bridget O’Malley has managed to stay in her own home and avoid having a second leg amputated through the use of a cost-effective, non-invasive home device which increases arterial blood flow to the leg. However, she is the only patient in Mayo still receiving HSE funding for the ArtAssist device and one of very few in the country due to funding cuts.

Read the rest via Is funding cut a false saving? – The Irish Times – Tue, Jul 24, 2012.

ArtAssist®…The Arterial Assist Device®

Diana’s note: Yep, that’s our ArtAssist® device! As you read the article further, you’ll see another story like Mrs. O’Malley’s, except that Mr. Conneely does not receive financial assistance for his device – he must pay out-of-pocket for it. Stateside, at ACI Medical, we’ve likewise been fighting for Medicare to reimburse for the ArtAssist® device because, as Dr. Sultan states in this article, having a patient on a device instead of undergoing a costly amputation really is “a no-brainer”.

Jul 24, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

Andrew Nicolaides scheduled to talk about the ArtAssist® Device at Veith Symposium 2012

We are excited to announce that at this year’s Veith Symposium in New York, Professor Nicolaides will be giving a short presentation about our own ArtAssist® pneumatic compression device.

As one of the ArtAssist® Device’s key developers, Prof. Nicolaides is a veritable expert on the machine’s capability to treat non-surgical patients suffering from severe PAD. If anyone can give a great 5-minute talk about our new technology at 6:46 a.m., it would be him.

Are you attending Veith 2012? Roll out of bed, grab some coffee (or whatever you do to wake up…I don’t judge), get dressed with as much coordination as you can muster, and make your way down to the lecture hall on Friday, November 16 from 6:46 – 6:51 a.m. to listen to “How The Art-Assist Pneumatic Compression Device Can Heal Ulcers From CLI And Relieve Rest Pain Noninvasively.”

As a man of vast knowledge, Prof. Nicolaides will also be presenting on a couple of other topics. Check out his schedule by clicking here.

All stents fail. So what happens next? (acimedical.wordpress.com)

Jul 17, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

Research at the Imperial College of London suggests IPC therapy helps keep arterial bypass grafts in shape

ArtAssist®…The Arterial Assist Device®

Research carried out at the Imperial College in London shows that an intermittent pneumatic compression (IPC) therapy regimen applied to lower limbs with peripheral arterial disease (PAD) can extend the life and efficacity of infrainguinal arterial bypass grafts. Starting with the knowledge that IPC already dramatically enhances blood flow to the lower extremities, researchers in London tested their hypotheses on patients who had already undergone successful bypass surgery in hopes that IPC therapy would improve the performance of the new vascular system. They were not disappointed.

“IPC was effective in improving infrainguinal graft flow velocity, probably by reducing peripheral resistance,” states the last line of one abstract of a study led by Konstantinos Delis, MD, PhD. “IPC has the potential to reduce the risk of bypass graft thrombosis.”

Many patients with ischemic limbs choose to have a bypass procedure done to restore arterial blood flow to their lower extremities. Though bypass procedures are often a reliable treatment solution for limb ischemia, the newly-revascularized limb is still susceptible to returning to its atherosclerotic state if regular blood flow is not maintained.

To prevent return of this disease’s symptoms, some patients are able to exercise regularly. Others, however, remain in danger of being revisited by PAD’s painful consequences.

This is where IPC therapy comes in: by sequentially compressing the foot, ankle and calf, IPC mimics the physiological benefits of taking a brisk walk. Both walking and IPC activate the calf muscle pump, which pushes venous blood back towards the heart to be re-oxygenated and sent back to the legs at a greater velocity. This increase in blood flow effectively increases chances of recovery from the effects of PAD.

In one study, researchers at the Imperial College of London applied an IPC device to patients who had already successfully undergone an arterial bypass graft (femoropopliteal & femorodistal). Five outcome measures, including volume flow in the grafts, yielded encouraging results directly after IPC therapy. Blood flow had improved significantly in all areas for both types of bypass grafts.

Having one more option for maintaining healthy blood flow to the lower limbs could dramatically change a PAD patient’s quality of life by decreasing the number of surgical procedures and time spent in the hospital.

The IPC device used in this clinical study was the ArtAssist® Arterial Pump developed by ACI Medical, LLC.

Reference:

Haemodynamic Effect of Intermittent Pneumatic Compression of the Leg After Infainguinal Arterial Bypass Grafting. Delis, K. et al. St. Mary’s Hospital, Imperial College School of Medicine, London, UK. Br J Surg 2004; 91: 429-34

Other studies of interest:

Enhancing Foot Skin Blood Flow in Patients with Infrainguinal Arterial Bypass Grafting Using Intermittent Pneumatic Compression. Husmann, M.J.W.; Delis, K.T.; Lennox, A.F.; Nicolaides, A.N.; Standsby, G. Irvine Laboratory for Cardiovascular Research, St. Mary’s Hospital, London, UK. 21st Conference in Microcirculation, June 2000

Effects of Intermittent Pneumatic Compression of the Calf and Thigh on Arterial Calf Inflow: A Study of Normals, Claudicants, and Grafted Arteriopaths. Delis, K.T.; Husmann, J.W.; Cheshire, N.J.; and Nicolaides, A.N. Imperial College School of Medicine, St. Mary’s Hospital, London, UK. Surgery, 2000, Vol. 129, No. 2, p. 188-195

Enhancing Foot Skin Blood Flux in Peripheral Vascular Disease Using Intermittent Pneumatic Compression: Controlled Study on Claudicants and Grafted Arteriopaths. Delis, K.T.; Husmann, M.J.W.; Nicolaides, A.N.; Wolfe. J.H., and Cheshire, N.J., Imperial College School Of Medicine, St. Mary’s Hospital, London, UK. World Journal Surgery, 2002 Jul;26(7):861-6

Andrew N. Nicolaides on IPC’s potential to enhance endovascular procedures (video)

Jul 12, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

The Gift of Limb Salvage: Claire’s Experience with the ArtAssist® Device

“Try it! What do you have to lose except your leg! It’s worth it and there’s absolutely no pain!” – Claire T., Tucson, AZ

ArtAssist®…The Arterial Assist Device®

As I may have mentioned before, knowing that our product changed someone’s life for the better makes all of our work WORTH IT. Claire’s life as she knew it was about to take a turn for the worse, so when her doctors recommended she try the ArtAssist® Arterial Assist Device®, she jumped at the chance.

Claire and her daughter co-wrote our staff a wonderful letter, chronicling her entire experience:

Dear Don and Sylvia,
I am helping to write this letter with my mom (Claire T. / Tucson, Arizona) to give you a little documentation how the ArtAssistDevice has helped to save her leg. Here is the time sequence:

My mom had a cadaver artery put in her right leg in order to possibly save her leg. (Advanced PAD disease). This was in March of 2011.

In early August, the cadaver artery stopped working because the smaller arteries in my mom’s feet became too narrow. No more surgery could be done. She goes on Vicodin for the pain.

Later part of August 2011, Dr. Luis L mentioned that if he could get the device, would she be willing to try it in order to save her leg. She said “YES!”

Device arrives on September 6, 2011 and she immediately uses it for 1 hour /3 times a day / 7 days a week. A lot of pain in her right leg. She is sleeping very little because of pain by the end of the second week, there is remarkable improvement. She can walk without pain in her leg for short distances and sleeps for about 4 hours before the pain returns. By the first part of October, she starts to use the device for 4 times a day. We travel to Phoenix for her grandson’s wedding and she is able to attend! Pain in the leg has diminished quite a bit but there is still tingling in the foot and toes.

By December, she gets off of pain pills and only takes Tylenol.

By the first part of January, the tingling in her toes is gone. She drops the times using the device to 3 times a day.

By February, she is walking for about ½ mile every day for about 20 minutes.

In March, the Doppler from Dr. Michael L shows her blood flow in that leg has increased quite a bit. She cuts back on the number of times per day to 1 or 2.

In late March, she develops a small but deep ulcer on her toe on her right foot. It becomes infected. (Sorry No Pictures. It was too small to show up on my camera) Dr. L is concerned that he might have to amputate it. He tells her to use the machine. She goes back to using it 1 hour 3 times per day. The toe within 2 weeks has improved dramatically so amputation is not discussed any more.

In mid June, she has another Doppler. It shows more collaterals being made and something was said that an artery that was previously blocked is no longer and he could use it in a bypass if he had to! The ulcer still has a scab but no longer hurts her.

She is currently using the machine for 1 hour/ 3 times per day. She is able to walk ½ mile daily with minimal pain. The pain comes in her calf but only lasts for 1 or 2 minutes and then she starts walking again.

If it wasn’t for your machine, the doctors have said she would have lost her leg. We believe this. We have seen it. It is a wonderful gift.

Thank you also for the wonderful customer service. You were always such a big help.

Sincerely,
Claire T.
Evelyn F.

Big thanks to Claire and her daughter for sharing their uplifting story with us!

Claire T. has given this information freely and has been made aware of her rights to the content she has provided via written consent.

Jun 27, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

The cost of lower-limb amputation

Recently, while summarizing key studies for a history and literature review that I’m working on, I was reminded that this particular

Always remember to look for clinical evidence.

study (the abstract is below) also included comparative costs. Update: download the finished History and Literature Review.

In this case, you will see that although SCBD (in other words, the ArtAssist® device) therapy doesn’t seem cheap at first, it’s still less than half the average cost of a primary amputation.

Want to hear even better news? This study yielded an 88% limb salvage rate, even after 18 months.

Edit: A 3-month rental of ArtAssist®…The Arterial Assist Device® in the United States ($1200) is more than 36 times less expensive than the cost of primary amputation per patient, according to the following study. And even if you take the SCBD patient cost (below), it still sounds like a better deal to me.

Nonoperative Active Management of Critical Limb Ischemia: Initial Experience Using a Sequential Compression Biomechanical Device for Limb Salvage

Sherif Sultan; Olubunmi Esan; Anne Fahy

Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital Galway, Galway, Ireland

Vascular 2008;163:130-139

Critical limb ischemia CLI patients are at high risk of primary amputation. Using a sequential compression biomechanical device SCBD represents a nonoperative option in threatened limbs. We aimed to determine the outcome of using SCBD in amputation-bound nonreconstructable CLI patients regarding limb salvage and 90-day mortality.

Thirty-five patients with 39 critically ischemic limbs rest pain = 12, tissue loss = 27 presented over 24 months. Thirty patients had nonreconstructable arterial outflow vessels, and five were inoperable owing to severe comorbidity scores. All were Rutherford classification 4 or 5 with multilevel disease. All underwent a 12-week treatment protocol and received the best medical treatment.

The mean follow-up was 10 months SD ± 6 months. There were four amputations, with an 18-month cumulative limb salvage rate of 88% standard error [SE] ± 7.62%. Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 67 mmHg SD ± 33.7, 95% confidence interval [CI] 55 – 79. Popliteal artery flow velocity increased from 45 to 47.9 cm/s 95% CI 35.9 – 59.7. Cumulative survival at 12 months was 81.2% SE ± 11.1 for SCBD, compared with 69.2% in the control group SE ± 12.8% p = .4, hazards ratio = 0.58, 95% CI 0.15 – 2.32. The mean total cost of primary amputation per patient is €29,815 ($44,000) in comparison with €13,900 ($20,515) for SCBD patients.

SCBD enhances limb salvage and reduces length of hospital stay, nonoperatively, in patients with nonreconstructable vessels.

Jun 11, 2012 By acimedical ArtAssist®...The Arterial Assist Device®, PAD

ACI Medical President interviewed by Medical Marcom’s Joe Hage

Yesterday, Ed participated in a #MedDevice interview titled “ACI Medical became a contract manufacturer…’because our vendors sucked'”, which you can read in its entirety here (you’ll need a Linkedin account).

He and Joe talked a lot about what makes ACI Medical the company it is today, from its humble beginnings as a couple of guys working in a garage with second-hand machinery to the quality products and services that make our customers glad they’re with us.

I hope you enjoy reading the interview as much as we enjoyed doing it!

Jun 7, 2012 By acimedical ACI Medical, ArtAssist®...The Arterial Assist Device®, Contract Manufacturing

I’m now 89 and still have my limbs – Lorraine K. in Grand Forks, ND

Lorraine K. of Grand Forks, ND was diagnosed with severe PAD. For treatment, she at first received a calf-only pneumatic compression device from her hospital. After using this system for a week, she decided that the pressure was too weak and that she was unsatisfied.

Her doctor at the Mayo Clinic in Rochester, MN, then prescribed ArtAssist®…The Arterial Assist Device® for Lorraine in 2002. She was told to use it 4-6 hours a day. Later that year, Lorraine purchased our pump and began to use it in early 2003. She noticed an immediate difference, saying that ACI Medical’s arterial pump “blew [the calf-only system] out of the water.” Since her purchasing of the ArtAssist® device, Lorraine has sent it back to ACI Medical only once for repairs and uses it faithfully for the prescribed amount of time each day.

Lorraine’s only suggestion for the ACI Medical team is to “get the word out” about the therapy that has helped her so much. Sometimes, we receive thank you letters from Lorraine. So, in that spirit, here is a letter she wrote to Don Kjartanson, our Director of Sales & Marketing:

Dear Don,

I wish to thank you for all the good service you have given me, especially for the new blue cuffs, nice to have some color.

The Dr.’s of Rochester, MN have really been surprised to see how well I’ve been doing with my machine. That’s the only thing that keeps me going. I think I’m in the 11^th year so am so happy to have found out about this machine. If anyone wants to write to me, I’ll be happy to hear.

Use my remarks as you wish.

And thanks so very much. I could not afford what you’ve given me.

Keep up the good work.

Sincerely,

Lorraine K.

Diana’s note: I hope you enjoyed reading Lorraine’s sweet note, because patients like her really put the cherry on top of the cake! Even though we already believe in ArtAssist® Arterial Pump Technology as a way to treat PAD, it’s a great feeling to hear from actual patients who need the device. And that, my friends, is what should drive a marketing department!

Update

Since the above entry was based on a telephone conversation and a greeting card, the customer service team at ACI Medical has been reaching out to patients who wish to share their stories. Since Lorraine always has something to add, we invited her to send us all of her thoughts. Among all of our patients, she is certainly one of the most informed about the ArtAssist® device, as she has been using it for almost 12 years! I hope you enjoy her account of how she went from fearing for her limbs to leading a happy, functional life in her own home.

Q: When it comes to ACI Medical’s customer service, what stands out to you?

To me it’s the very best, very good service. They have always treated me well, they take an interest in you.

Q: What would you say to a friend, who was looking for a non-surgical solution for PAD, about the ArtAssist® device?

I would say, go for it you have nothing to lose but the pain, it may take a while to get results, so give it time.

Q: Who prescribed the ArtAssist® device for you?

My son Alvin went to the libraryand got the Reader’s Digest. This is where I found the ArtAssist advertisement, so I contacted the company. They sent me information, and after reading about the ArtAssist machine I went ahead and ordered it. I am so glad we ran across this article. It’s great.

Further thoughts

In March 28, 1996, I had a history of lower peripheral arterial occlusive disease, which had been long standing. I had a left femoral below the knee popliteal bypass graft, which failed in 1999. I had critical lower extremity occlusive disease and was referred for medical treatment. Dr. has been following me since 2000 for this problem. I had severe bilateral peripheral arterial occlusive disease, right 4th toe ulcer to ischemia, in heels then corroded briuts (?) hypertension. I used antifungal cream, I would get pain in calves & feet at a distance of walking across the room, both lower extremities are equally involved. I was using the ArtAssist pump 3 times a day, 90 minutes each hour, it’s remarkable after 11 to 12 years period of no limb loss has ensued. I maintain my activities of daily living and household duties. I have my own house. My son who is disabled lives with me, which is a big help. Dr. says given my age I am doing remarkable with my disease status. I’m now 89, and still have my limbs.

The ArtAssist compression pump is a therapeutic product, a powerful therapy for increasing blood flow with patients effects are for better than any other and without side effects, this has a unique form of pneumatic compression to the patients with diabetic foot ulcers, intermittent claudication, rest pain or non-surgical candidates, have seen positive results with this new technology.

The ArtAssist is very easy to use and very reliable. I look forward to using it, the compression cuffs are durable and designed to last for months of therapy. I am very lucky to have found something that has helped me so much, and I still have my limbs, the medical Dr.’s did all they could and after I got the ArtAssist device, which they didn’t seem to know anything about this machine, but they were happy for me and that I’m doing so well with it. I always use it 3 times a day. It’s the best. You will never find anything better.

Lorraine K.

Jun 5, 2012 By acimedical ArtAssist®...The Arterial Assist Device®, PAD

Why ArtAssist® arterial pump therapy is unique

When you think of therapeutic pneumatic compression pumps, what comes to mind? Many might think of lymphedema or DVT prophylaxes, but it is less widely-known that arterial pump compression therapy, if correctly applied, can actually treat severe PAD.

ArtAssist®…The Arterial Assist Device®

ArtAssist®…The Arterial Assist Device® (Arterial Pump Technology) should not be confused with lymphedema or DVT prevention treatment because the ArtAssist® device solves an entirely different problem: facilitating arterial blood flow to the places that need it, especially in the legs and feet (there are also cuffs available for arms, though it is somewhat less common).

So, for example, if you have atherosclerosis (hardening of the arteries) of the lower extremity or a diabetic foot ulcer, your problems would not be solved with a lymphedema pump, even if it has been modified to be more powerful. (Side note: some arterial pump makers advertise that a more powerful lymphedema or DVT pump will effectively treat arterial disease. We at ACI Medical suggest that you ask for their clinical evidence.)

Depending on the nature and severity of your arterial disease, you may be better advised to use the ArtAssist® device. This device was not based on a lymphedema or DVT pump design – rather, the ArtAssist® device was designed by vascular surgeons with the goal of increasing arterial flow for patients with poor leg circulation.

Researchers have discovered that, unlike lymphedema pump technology, the ArtAssist® device promotes what we call arteriogenesis, or collateralization. These two synonyms refer to the opening of small collateral arteries that already naturally bypass the obstructed artery. We all have these small collateral arteries, but when the main artery has no blockages, the collateral ones aren’t needed.

angiogram van bemmelen artassist arterial pump technology

Arteriogenesis (or collateralization) explains why patients have long-term results after stopping ArtAssist® device usage

In this case, a person with a blocked artery needs to take action so that blood gets where it needs to be. Sometimes, people make lifestyle changes, such as dieting and exercising. Other times, people take medication to improve blood flow. And in more severe cases, people resort to surgery such as bypass and endovascular procedures (e.g. stenting, angioplasty, etc.).

The problem is that some people exhaust all of those options and vascular surgeons believe they have no other choice but to amputate – but that’s not true! There is actually one last shot at limb salvage for these patients, and that is the ArtAssist® device. In one clinical study, it was shown to have up to a 94% limb salvage rate even after 3.5 years.

Do be advised, though: no one would ever recommend that you let it get to the point of amputation. As with all diseases, the earlier you solve the problem, the better.

If you or someone you know could use the ArtAssist® device as a non-surgical solution for PAD, please call our toll free number 888-453-4356 and ask to talk to Don or Sylvia. If you contact me (via WordPress, Twitter, Facebook, email, website, etc.), I will refer you to either of the two people I just mentioned as quickly as I can – we know how important limb salvage is.

Jun 4, 2012 By acimedical ArtAssist®...The Arterial Assist Device®

He speaks! The inventor of the ArtAssist® device

Please enjoy this video of Ed Arkans, MEng (President of ACI Medical), as he gives you a brief overview of the device that successfully saves the limbs of non-surgical PAD patients: ArtAssist®…the Arterial Assist Device®

May 30, 2012 By acimedical ArtAssist®...The Arterial Assist Device®