Medtronic’s ‘Vascular Tubes and Catheters for Cardiopulmonary Surgery’ Granted Urgently Needed Rare Medical Device Designation
On the 31st, the Food and Drug Safety Administration designated four newly developed products by Medtronic as ‘urgently needed rare medical devices’. Among these products is the ‘DLP Pediatric One-Piece Artery Cannulae’, a crucial tool for cardiopulmonary surgery.
Understanding the Importance of Catheters in Cardiopulmonary Bypass
During cardiopulmonary bypass, a catheter plays a vital role by being inserted into the cardiovascular system and serving as a connector to a heart-lung machine. This surgical technique temporarily bypasses the functions of the heart and lungs, allowing for safe and effective open heart surgery.
Joo Seon-tae, the head of the Medical Device Policy Division at the Ministry of Food and Drug Safety, highlighted the significance of Medtronic’s product. He explained, “The connector diameter of 0.48 cm, which is smaller than the 0.64 cm connector found in other Korean-distributed products, makes it ideal for pediatric patients around 1 year old. This product not only prevents air inflow into blood vessels but also effectively reduces the risk of myocardial infarction and cardiac arrest caused by embolism.”
Furthermore, Joo Seon-tae emphasized the added benefit of supplying an additional 2.0 mm (6 Fr) catheter, previously unavailable in Korea. This expansion of product choices is expected to broaden treatment opportunities for pediatric patients.
Expediting the Access to Urgently Needed Medical Devices
Patient access to these urgently needed medical devices will be facilitated by the newly awarded designation. Starting from August, both patients and medical institutions can apply for product supply. Following the application, customs clearance is expected to take approximately a month, after which the devices can be utilized without insurance coverage until around November, as stated by the Ministry of Food and Drug Safety.
Park Chun-soo, a professor of pediatric cardiology at Seoul Asan Medical Center, who spearheaded the application for urgent designation of vascular tubes and catheters for cardiopulmonary surgery, expressed his hopes for improved pediatric patient care. He stated, “The introduction of these vascular tubes and catheters for cardiopulmonary surgery in Korea will align with the unique needs of pediatric patients. This development opens up the possibility of performing safer operations.”
Four products, ‘vascular tubes and catheters for cardiopulmonary surgery’ developed by Medtronic, were newly designated as ‘urgently needed rare medical devices’ by the Food and Drug Safety Administration on the 31st. The product is called ‘DLP Pediatric One-Piece Artery Cannulae’.
A ‘catheter’ is the device that is inserted into the cardiovascular system during cardiopulmonary bypass, and is a product that combines a ‘connector’ to connect to a heart-lung machine. Here, cardiopulmonary bypass refers to a surgical technique that temporarily bypasses the functions of the heart and lungs with a mechanical device to perform open heart surgery safely and efficiently.
Vascular tube catheter for cardiopulmonary surgery / Photo = Ministry of Food and Drug Safety
Joo Seon-tae, head of the Medical Device Policy Division of the Ministry of Food and Drug Safety, said, “The product has a connector diameter of 0.48 cm, which is smaller than the 0.64 cm connector of products distributed in Korea, so it is suitable for pediatric patients around 1 year old.” It can prevent air inflow into blood vessels, so it can prevent myocardial infarction and cardiac arrest due to embolism.”
In addition, he added, “By supplying an additional 2.0 mm (6 Fr) catheter, which was not available in Korea, we expect to expand the range of product choices and help expand treatment opportunities for pediatric patients.”
With the new designation of urgently needed rare medical devices, patients and medical institutions can apply for product supply from August. According to the Ministry of Food and Drug Safety, it can be supplied to medical sites after a period of about a month, depending on the customs clearance situation after application, and can be used without insurance until around November.
Park Chun-soo, professor of pediatric cardiology at Seoul Asan Medical Center, who applied for designation as a rare and urgently needed medical device for vascular tubes and catheters for cardiopulmonary surgery, said, “If vascular tubes and catheters are introduced for cardiopulmonary surgery in Korea, they will be suitable for the characteristics of pediatric patients. We hope that a safe operation will be possible.”
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