IN.PACT Admiral Drug-Coated Balloon Achieves 98.8% Freedom from Major Amputation in French Real-World Registry
Medtronic
Medical Device Manufacturer
Medtronic AnnouncesIn.Pact AdmiralResults of the French Quality of Life Registry Study. This study aims to evaluate patients receivingIn.Pact AdmiralChanges in quality of life, pain levels, and walking ability within 24 months after treatment.
This study was conducted across eight centers in France, enrolling a total of 80 patients with new onset obstructive lesions in lower extremity peripheral arteries, among whom 27.5% were Rutherford class 5 at baseline. The all-comer design allowed the study to cover patients and lesion conditions of high complexity, with lesions mainly located in the femoropopliteal artery segment.
Specific Research Results
From baseline to 12 months, both the quality of life assessed by the EQ-5D-5L scale and the walking ability assessed by the Walking Ability Questionnaire achieved statistically significant improvements, with the most significant improvement observed in patients with the lowest baseline quality of life scores.
The proportion of patients with critical limb ischemia decreased from 32.5% at baseline to 3.0% at 12 months, and 53.7% of patients reached an asymptomatic state at 12 months.
During the 24-month follow-up period, excellent clinical outcomes were demonstrated: a target vessel revascularization-free rate of 84.4%, a major amputation-free rate of 98.8%, and an all-cause mortality-free rate of 84.5%.
IN.PACT Admiral
IN.PACT AdmiralIt is a product suitable for percutaneous transluminal angioplasty (PTA) treatment of peripheral arterial occlusive disease, including in-stent restenosis (ISR), as well as obstructive lesions in native or arteriovenous dialysis fistulas.
IN.PACT AdmiraThe reason for having drug release technology that leads competitors is due to itsUsing the Admiral 0.035PTA balloon as the platform, with a crystalline paclitaxel drug concentration of 3.5ug/mm², the excipient is hydrophilic urea, and the coating process is Medtronic’s uniform, controllable, and quantifiable drug coating technology.
Paclitaxel can inhibit the proliferation, migration, and phenotypic transformation of vascular smooth muscle cells. The larger the dosage, the more significant the inhibitory effect on intimal hyperplasia. HoweverAnimal experiments have shown that the ideal concentration of paclitaxel for inhibiting intimal hyperplasia is between 2-4 µg/mm². Concentrations lower than this range are less effective, and concentrations exceeding 4 µg/mm² show no significant difference in effect compared to the 2-4 µg/mm² range. Therefore, Medtronic scientifically determined the optimal paclitaxel concentration to be 3.5 µg/mm².
IN.PACT AdmiraUrea is used as an excipient, providing multiple advantages: 1. Urea is hydrophilic, facilitating drug release in the affected area with higher tissue concentration compared to hydrophobic excipients; 2. Urea has a lower loss rate during delivery compared to other hydrophilic coatings and demonstrates higher transport efficiency in tissues; 3. Urea is a natural molecule in the human body with extremely low toxicity, no allergic reactions, and the maximum urea dose on the balloon surface is only 1/20,000 of the daily production in the human body, making the dosage extremely small.Thereby ensuringIN.PACT AdmiraDrug release lasts up to 180 days。
IN.PACT AdmiraIn addition to drugs andExcipientIn addition to its advantages, it also has up to 7 different balloon lengths (From 40mm to 250mm), making it suitable for different types ofPeripheral Arterial Occlusive Disease。
