Medtronic has secured an expanded Conformité Européenne (CE) mark approval for its Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, commonly referred to as a drug-coated balloon (DCB).
This catheter is now cleared for a wider range of treatments, including complex bifurcation lesions, multivessel disease, acute coronary syndrome, and diabetes in patients suffering from coronary artery disease (CAD).
The enhanced CE Mark authorisation follows a successful demonstration of the Prevail DCB’s performance in real-world settings, as documented in data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
According to a late-breaking clinical trial showcased at Cardiovascular Research Technologies, the device showed promising results over two years with low event rates of 6.1% for new myocardial infarction, 7.4% for target lesion revascularization, and 0.8% for target lesion definite thrombosis.
In hybrid percutaneous coronary interventions, where both the DCB and drug-eluting stent are used in the same vessel, the Prevail DCB reported lower incidences of new myocardial infarctions compared to other DCBs.
Further evidence was revealed during a subgroup analysis at EuroPCR, demonstrating favourable outcomes for bifurcation lesions with low mortality and revascularisation rates.
At one-year, patient data indicated a 2.3% rate of new myocardial infarction, 2.8% rate of target lesion revascularization, and a 0% rate of target lesion definite thrombosis. These findings suggest that the Prevail DCB is an effective treatment strategy across various complex coronary lesions.
Coronary artery disease affects more than 315 million individuals worldwide and arises when arteries that supply blood and oxygen to the heart become narrowed or obstructed due to plaque accumulation.
Drug-coated balloons are increasingly recognised as a viable treatment option and are particularly gaining momentum in addressing bifurcation lesions, which are considered challenging due to their complexity.
Medtronic senior vice president and cardiovascular portfolio coronary and renal denervation business president Jason Weidman said: “The Prevail DCB’s acute performance, clinical data, and expanded indications support the needs of physicians who treat increasingly complex patients. We are taking the same approach we’ve taken over the years with our drug-eluting stents.
“By bringing real world clinical data to the forefront, we can expand use of the Prevail DCB in new patient populations.”
Prevail DCB was first introduced in Europe in 2021 for treating de novo lesions, in-stent restenosis, and small vessel disease within coronary arteries. It features FreePac coating.
Presently available commercially in over 80 countries, its use remains investigational within the US and Japan.
Separately, Medtronic has entered into a distribution agreement with Corsano Health, allowing it to exclusively distribute the latter’s multi-parameter wearable technology across Western Europe. The partnership will facilitate the use of advanced remote monitoring solutions in both hospital and home settings, aiming to enhance patient care through improved monitoring capabilities.
The Corsano wearable device offers continuous monitoring of vital signs, including heart rate, breathing rate, SpO2, blood pressure, and ECG. This non-invasive solution is designed to provide real-time data to healthcare professionals, enabling them to monitor patients effectively across various settings.
Earlier this week, Medtronic has announced plans to separate its diabetes business into a standalone entity named “New Diabetes Company.” This move aims to streamline Medtronic’s portfolio, focusing on high-growth markets while establishing the New Diabetes Company as an independent leader in diabetes care, committed to advancing innovation in insulin management.
