First patients treated with reSept ASD occluder in IDE trial
Ngày 15/07/2021 10:30 | Lượt xem: 35

atHeart Medical has announced the successful treatment of the first five patients in its ASCENT ASD US Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the USA, will evaluate the safety and efficacy of the reSept atrial septal defect (ASD) occluder.

The initial patients were treated by Thomas Jones, cardiac catheterization laboratory director at Seattle Children’s Hospital (Seattle, USA), Scott Lim, medical director of the Advanced Cardiac Valve Center at the University of Virginia (Charlottesville, USA) and Thomas Forbes, director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan (Detroit, USA). The prospective, single-arm study will enrol up to 250 patients at multiple sites globally. Primary endpoints will be compared with established performance goals for previously US Food and Drug Administration (FDA)-approved transcatheter ASD occluders.

“I am pleased to be a part of this study and advance therapy options for septal defects that leave a minimal footprint behind. The reSept ASD occluder implanted easily and had a successful outcome with no residual shunts,” commented Jones. “We look forward to continuing enrolment and further validation of this promising technology.”

Current ASD occluders have metallic frames that can place patients at risk for complications and prohibit future transseptal interventions. Initial clinical experience demonstrates effective closure of the ASDs treated with the company’s device.

“The metal-free frame of the reSept ASD occluder provides a low-profile that over time is replaced by the patient’s tissue, leaving minimal implant behind and restoring a more natural septum when compared to current occluder devices,” stated Saibal Kar, Los Robles Regional Medical Center in Thousand Oaks, USA and co-principal investigator of the IDE trial. “This provides a unique opportunity for physicians to effectively address ASDs while being mindful of our patient’s potential need for subsequent transseptal procedures.”

“I am pleased to have such a strong start to this important pivotal trial and it is incredibly exciting to have the participation of so many leading institutions,” said Laurent Grandidier, CEO of atHeart Medical. “I commend the team’s diligence to expanding the body of evidence supporting our reSept device and dedication to delivering this lifesaving innovation to patients around the world.”

Source CardiovascularNews

Duc Tin Clinic

Print Chia sẽ qua facebook bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua google bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua twitter bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua MySpace bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua LinkedIn bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua stumbleupon bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua icio bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua digg bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua yahoo bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua yahoo bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua yahoo bài: First patients treated with reSept ASD occluder in IDE trial Chia sẽ qua yahoo bài: First patients treated with reSept ASD occluder in IDE trial

Tin tức liên quan

CUSTOMER REVIEWS

  • I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

    I sincerely thank you !. Tel: 0938303275

  • Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

    Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

  • As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

  • The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

  • I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search
Customer support

    Phone: (028) 3981 2678
    Mobile: 0903 839 878 - 0909 384 389

TOP