Two in ten severe MR patients can die within one year without intervention.4,5*
*Study data includes both DMR and FMR patients
Treatment options
Historically, there have been two main treatment options for patients with degenerative regurgitation (DMR) — guideline-directed medical therapy (GDMT) and surgical intervention strategies. Treatment options vary depending on the type of MR.1
Despite millions of cases in an aging population, DMR is still substantially undertreated2
Surgery saves lives, but many patients do not meet the criteria
Only 15% of patients diagnosed with moderate or severe MR underwent valve surgery.3
96.3% one-year survival rate for patients with severe, symptomatic MR who received surgical intervention.3*
*79% of the study population had DMR vs. 21% FMR or other.
Many patients with severe MR go untreated, post 2 years diagnosis.6
A less invasive option is needed for patients at high surgical risk7
CLASP IID [trial] matters to the treatment team, it matters to the referring cardiologist, and most importantly, it matters to the patient. Now you can look at the patient in the eye and say, "Based on the available data, I know that if we treat your mitral regurgitation, you're going to have improvement in your quality of life.
-Firas Zahr, MD
Oregon Health and Science University
Transcatheter edge-to-edge repair (TEER) has shown significant and sustained MR reduction and durable patient benefits.8
In the CLASP IID trial, TEER has shown significant and sustained MR reduction in patients with severe, symptomatic DMR at prohibitive surgical risk at 2 years.
79% of patients achieved significant and sustained MR reduction (MR≤1+)*
88% of patients achieved NYHA class I/II
89% freedom from cardiovascular mortality
+17 points KCCQ-OS improvement
*Data from unpaired analysis. The presented MR reduction was achieved using the PASCAL system.
KCCQ-OS: Kansas City Cardiomyopathy Questionnaire Overall Summary Score; NYHA: New York Heart Association.
Help your patients start a new chapter with TEER by Edwards
References
- Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e72–227. doi:10.1161/CIR.0000000000000923.
- Taramasso M, Gaemperli O, Maisano F. Treatment of degenerative mitral regurgitation in elderly patients. Nat Rev Cardiol. 2015;12(3):177–83. doi:10.1038/nrcardio.2014.210.
- Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet. 2018;391(10124):960–969. doi:10.1016/s0140-6736(18)30473-2.
- Welman, M.J.M.; Streukens, S.A.F.; Mephtah, A.; Hoebers, L.P.; Vainer, J.; Theunissen, R.; Heuts, S.; Maessen, J.G.; Segers, P.; Vernooy, K.; et al. Outcomes of Mitral Valve Regurgitation Management after Expert Multidisciplinary Valve Team Evaluation. J. Clin. Med. 2024, 13, 4487.
- Goel SS et al. Prevalence and Outcomes of Unoperated Patients With Severe Symptomatic Mitral Regurgitation and Heart Failure: Comprehensive Analysis to Determine the Potential Role of MitraClip for This Unmet Need. J Am Coll Cardiol. 2014;63(2):185-190
- Sharma, R, Cubeddu, R, Genereux, P. et al. TCT-447 Contemporary Practice Patterns and Outcomes for Patients With Mitral Regurgitation: Results From a Large Multicenter Real-World Database. JACC. 2023 Oct, 82 (17_Supplement) B179–B180. https://doi.org/10.1016/j.jacc.2023.09.456
- Lung B, Urena M. New insights into transcatheter edge-to-edge repair: Filling a gap for undertreatment of primary mitral regurgitation in the elderly? Eur Heart J. 2022;0(0) doi:10.1093/ eurheartj/ehac039.
- Zahr F, et al. CLASP IID Randomized Trial and Registry: Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation. Presented at: TCT Annual Congress; 2024 Oct 30; Washington, DC.
Important Safety Information
Important Safety Information
Edwards PASCAL Precision Transcatheter Valve Repair System
Indications: The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR.
Contraindications: The PASCAL Precision system is contraindicated in patients with the following conditions: patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; untreatable hypersensitivity or contraindication to nitinol alloys (nickel and titanium) or contrast media; active endocarditis of the mitral valve; rheumatic etiology for mitral regurgitation; evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
Warnings: The devices are designed, intended, and distributed for single use only. There are no data to support the sterility, non-pyrogenicity, and functionality of the devices after reprocessing. Devices should be handled using standard sterile technique to prevent infection. Do not expose any of the devices to any solutions, chemicals, etc., except for the sterile physiological and/or heparinized saline solution. Irreparable damage to the device, which may not be apparent under visual inspection, may result. Do not use any of the devices in the presence of combustible or flammable gases, anesthetics, or cleaners/disinfectants. Do not use the devices if the expiration date has elapsed. Do not use if the packaging seal is broken or if the packaging is damaged for sterile devices. Do not use if any of the devices were dropped, damaged or mishandled in any way. Standard flushing and de-airing technique should be used during preparation and throughout procedure to prevent air embolism.
As with any implanted medical device, there is a potential for an adverse immunological response. Serious adverse events, sometimes leading to surgical intervention and/or death, may be associated with the use of this system ("Potential Adverse Events"). A full explanation of the benefits and risks should be given to each prospective patient before use. Careful and continuous medical follow-up is advised so that implant-related complications can be diagnosed and properly managed. Anticoagulation therapy must be determined by the physician per institutional guidelines.
Precautions: Prior to use, patient selection should be performed by a heart team to assess patient risk and anatomical suitability. After use, short-term anticoagulation therapy may be necessary after valve repair with the PASCAL Precision system. Prescribe anticoagulation and other medical therapy per institutional guidelines.
Potential Adverse Events: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the PASCAL Precision system: death; abnormal lab values; allergic reaction to anesthetic, contrast, heparin, Nitinol; anemia or decreased hemoglobin (may require transfusion); aneurysm or pseudoaneurysm; angina or chest pain; anaphylactic shock; arrhythmias – atrial (i.e. atrial fibrillation, Supraventricular tachycardia); arrhythmias – ventricular (i.e. ventricular tachycardia, ventricular fibrillation); arterio-venous fistula; atrial septal injury requiring intervention; bleeding; cardiac arrest; cardiac failure; cardiac injury, including perforation; cardiac tamponade/pericardial effusion; cardiogenic shock; chordal entanglement or rupture that may require intervention; coagulopathy, coagulation disorder, bleeding diathesis; conduction system injury which may require permanent pacemaker; deep vein thrombosis (DVT); deterioration of native valve (e.g., leaflet tearing, retraction, thickening); dislodgement of previously deployed implant; dyspnea; edema; electrolyte imbalance; emboli/embolization including air, particulate, calcific material, or thrombus; endocarditis; esophageal irritation; esophageal perforation or stricture; exercise intolerance or weakness; failure to retrieve any PASCAL Precision system components; fever; gastrointestinal bleeding or infarct; heart failure; hematoma; hemodynamic compromise; hemolysis; hemorrhage requiring transfusion or intervention; hypertension; hypotension; implant deterioration (wear, tear, fracture, or other); implant embolization; implant malposition or failure to deliver to intended site; implant migration; implant thrombosis; infection; inflammation; LVOT obstruction; mesenteric ischemia; multi-system organ failure; myocardial infarction; native valve injury; native valve stenosis; nausea and/or vomiting; need for open surgery (conversion, emergent or nonemergent reoperation, explant), nerve injury neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke; non-neurological thromboembolic events; pain; papillary muscle damage; paralysis; PASCAL Precision system component(s) embolization; peripheral ischemia; permanent disability; pleural effusion; pulmonary edema; pulmonary embolism; reaction to anti-platelet or anticoagulation agents; renal failure; renal insufficiency; respiratory compromise, respiratory failure, atelectasis, pneumonia – may require prolonged ventilation; retroperitoneal bleed; septal damage or perforation; septicemia, sepsis; skin burn, injury or tissue changes due to exposure to ionizing radiation; single leaflet device attachment (SLDA); stroke; syncope; transient ischemic attack (TIA); urinary tract infection and/or bleeding; valvular regurgitation; vascular injury or trauma, including dissection or occlusion; vessel spasm; ventricular wall damage or perforation; worsening native valve regurgitation / valvular insufficiency; worsening of heart failure; wound dehiscence, delayed or incomplete healing.
CAUTION: US law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.
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