Medtronic donates drug-coated balloons to help reduce the number of treatment interruptions for dialysis-dependent patients during the pandemic.
As the world faces COVID-19, patients living with kidney failure grapple with difficult decisions. Already considered vulnerable to illness, many require weekly trips to dialysis centers for treatment. In many cases, the risk of exposure to COVID-19 could pose an even greater risk, especially for a patient population where the number two cause of death remains infection.1
“Patients are still very worried about COVID-19 and their risk for infection,” said Terry Litchfield, president of Access Solutions, an organization focused on patient advocacy related to vascular access services. “They want to avoid going to the hospital, at all costs.”
Medtronic understands what’s at stake. It’s why the company announced a new $10 million product donation intended to help people living with end-stage renal disease (ESRD) continue their dialysis safely, with less interruption and with more limited exposure to the hospital.
“Our hope is to help reduce the likelihood of these at-risk patients being exposed to the virus,” said Mark Pacyna, vice president and general manager of the peripheral vascular business at Medtronic.
Medtronic is donating thousands of drug-coated balloons (DCBs) for use in AV fistulae to U.S.-based physicians performing access maintenance procedures. These DCBs are designed to reopen arteries and leave behind a drug intended to keep them open longer, helping the dialysis treatment continue safely. Over a six-month time period, the therapy allows for 56 percent fewer reinterventions.2
“We hope this donation program will help extend the time to reintervention and reduce these additional hospital visits,” said Pacyna. “Additionally, minimizing hospital exposure of ESRD patients enables resources to be available to address the pandemic.”
Hemodialysis — the process of purifying the blood for a person whose kidneys are not working normally — is just the beginning. Because this treatment, basically, cleans the blood, it requires access points in the patient’s arm for catheters to connect with veins. But those access points, called arteriovenous (AV) fistulae, often require multiple interventions, maintenance and physician care to remain functional. This means more visits to hospitals or medical facilities to get this important procedure.
On average, one to three interventions are needed each year to keep the AV fistula functioning.
“Patients are fearful,” said Litchfield. ““One less trip to a hospital or an access center is huge right now.”
The product donation is the company’s largest for this patient group and another effort to assist in responding to the global COVID-19 pandemic.
“Our company Mission calls us to contribute to human welfare by alleviating pain, restoring health, and extending life,” said Pacyna. “It’s the right thing to do to help ESRD patients during this uncertain time.”
Vogelzang, J.L. et al. Mortality from infections and malignancies in patients treated with renal replacement therapy: data from the ERA-EDTA registry. Nephrology Dialysis Transplantation. June 2015, Pages 1028–1037, https://doi.org/10.1093/ndt/gfv007
Holden, A. Primary Endpoint Results of The IN.PACT AV Access Randomized Trial: Outcomes Through Six Months. Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting. Barcelona, Spain. September 7, 2019.
The IN.PACT™ AV Paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm
The IN.PACT AV DCB is contraindicated for use in the following anatomy and patient types:
· Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
· Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
· Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
· Patients with known allergies or sensitivities to paclitaxel
· Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure
· A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2-3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Inadequate information is available to evaluate the potential mortality risk associated with the use of paclitaxel-coated devices for the treatment of other diseases/conditions, including this device indicated for use in arteriovenous dialysis fistulae. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options for their specific disease/condition with their patients.
· Use the product prior to the Use-by date specified on the package.
· Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
· Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
· Do not move the guidewire during inflation of the IN.PACT AV DCB.
· Do not exceed the rated burst pressure (RBP). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
· The safety of using multiple IN.PACT AV DCBs with a total drug dosage exceeding 15,105 μg paclitaxel has not been evaluated clinically.
· This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
· Assess risks and benefits before treating patients with a history of severe reaction to contrast agents. Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.
· This product is not intended for the expansion or delivery of a stent.
· Do not use the IN.PACT AV DCB for pre-dilatation or for post-dilatation.
· This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
· The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events
· The safety and effectiveness of the IN.PACT AV DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure has not been evaluated.
· The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
· Appropriate vessel preparation, as determined by the physician to achieve residual stenosis of ≤ 30%, is required prior to use of the IN.PACT AV DCB. Vessel preparation of the target lesion using high-pressure PTA for pre-dilatation was studied in the IN.PACT AV Access clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT AV DCB.
Potential Adverse Effects
Potential adverse effects which may be associated with balloon catheterization may include, but are not limited to, the following: abrupt vessel closure, allergic reaction, arrhythmias, arterial or venous aneurysm, arterial or venous thrombosis, death, dissection, embolization, hematoma, hemorrhage, hypotension/hypertension, infection, ischemia or infarction of tissue/organ, loss of permanent access, pain, perforation or rupture of the artery or vein, pseudoaneurysm, restenosis of the dilated vessel, shock, stroke, vessel spasms or recoil.
Potential complications of peripheral balloon catheterization include, but are not limited to, the following: balloon rupture, detachment of a component of the balloon and/or catheter system, failure of the balloon to perform as intended, failure to cross the lesion. These complications may result in adverse effects.
Although systemic effects are not anticipated, potential adverse effects not captured above that may be unique to the paclitaxel drug coating include, but are not limited to, the following: allergic/immunologic reaction, alopecia, anemia, gastrointestinal symptoms, hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia), hepatic enzyme changes, histologic changes in vessel wall, including inflammation, cellular damage, or necrosis, myalgia/arthralgia, myelosuppression, peripheral neuropathy.
Refer to the Physician’s Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time.
Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse effects. This content is available electronically at www.manuals.medtronic.com.