InSeal Medical Ltd., developer of percutaneous vascular closure devices for large bore punctures, today announced the successful treatment of three patients with its investigational intravascular large bore puncture closure device. InSeal aims to solve a significant surgical limitation in cardio-vascular procedures by providing physicians with the first device to percutaneously seal large bore punctures in blood vessels from the inside. The results were described today at the Transcatheter Cardiovascular Therapeutics 2011 scientific symposium.
“We are excited by the positive patient outcomes observed in the first clinical study of our next generation vascular closure device of large bore punctures,” said Avi Penner, PhD, Chief Executive Officer of InSeal Medical. “This feasibility study is an important milestone for the company, and the data will be included in the clinical evidence required to support a CE approval of the InSeal vascular closure device expected in 2012.”
“We are excited by the positive patient outcomes observed in the first clinical study of our next generation vascular closure device of large bore punctures,”
In the clinical trial, two patients aged 92 and 53 underwent full percutaneous transcatheter aortic valve replacement (TAVR) using an 18 French-sized large bore catheter. A third patient aged 82 received full percutaneous endo-vascular aneurysm repair (EVAR) using a 21 French-sized large bore catheter. In all three procedures, patients received the experimental InSeal Medical percutaneous vascular closure device, avoiding the need for current standard surgical cut-down procedures or complex suturing techniques.
The InSeal closure device achieved a complete acute sealing in each patient with no further bleeding or hematoma at the access site. Twenty-fours following the procedure, the trial’s patients began to ambulate and ultrasound testing revealed normal blood vessel flow. Patients were discharged from the hospital within 48 hours and no complications were reported through 30 days of follow-up.
“Having treated several hundred patients needing transcatheter aortic valve replacement and endovascular aneurysm repair, I am excited to use an innovative device that could significantly advance minimally invasive cardio-vascular repair and improve patient outcomes,” said Eberhard Grube, MD, the trial’s principal investigator and a professor of medicine at the University of Bonn, Germany. “I look forward to participating in the ongoing clinical development program.”
“We are very pleased to have successfully completed the first human procedures in the world with InSeal’s novel device,” said Alexandre Abizaid, MD, Chief of Coronary Interventions at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, where the procedures were performed. “Given our extensive experience with cardio-vascular repair and understanding the limitations of commercially available devices, we believe that this investigational device has the potential to address a significant unmet clinical need – a minimally invasive alternative for patients requiring transcatheter aortic valve replacement or endo-vascular aneurysm repair.”
The InSeal closure device was delivered into the access artery through large bore sheaths used in TAVR and EVAR procedures. The device is deployed across the puncture, with a biodegradable membrane patching the site. In the trial, delivery and deployment of the InSeal closure device took less than two minutes. The experimental device does not need sutures.
Transcatheter aortic valve replacement and endo-vascular aneurysm repair are two of the largest and fastest growing fields in cardio-vascular intervention. Transcatheter aortic valve replacement is an endovascular procedure to replace a diseased aortic valve. Aortic stenosis is a common problem affecting approximately two percent of people over age 65 and four percent of people over age 85. Endo-vascular aneurysm repair is an endovascular procedure to treat abdominal or thoracic aortic aneurysms, balloon-like enlargements of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with abdominal aortic aneurysms in the developed world and each year 600,000 new cases are diagnosed.
Source: Inseal Medical Ltd