login
  Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

Abbott launches MitraClip system in Australia


Friday, 15 Apr 2011 10:58
MitraClip
MitraClip


Abbott announced the launch of its catheter-based MitraClip system in Australia. The MitraClip device, which has received Therapeutic Goods Administration (TGA) approval, offers a new treatment option for patients suffering from mitral regurgitation.


This system includes a catheter-based device that is delivered to the heart through the femoral vein. It is designed to reduce significant mitral regurgitation by clipping together the leaflets of the mitral valve. Mitral regurgitation has traditionally been managed with medications, which can relieve symptoms but do not address the underlying cause of the condition, or open-heart surgery. According to Bach et al, many people who suffer from mitral regurgitation are not treated surgically because they are not referred to surgery, are not sick enough, or are too frail for an invasive procedure.

 

“The availability of the MitraClip system provides physicians with a safe, minimally invasive treatment for mitral regurgitation that may provide new hope for many people for whom surgery is not an option,” said Eric Yamen, Sir Charles Gairdner Hospital, Perth, Australia. “This therapy has the potential to improve the quality of life for many sick patients, enabling them to have a more active lifestyle.”

 

The first patients were successfully treated in Australia by interventional cardiologist, Eric Yamen; cardiothoracic surgeon, Jurgen Passage and echocardiologist, Christopher Finn; all from Sir Charles Gairdner Hospital, Perth, Australia.

 

Robert Hance, senior vice president, Vascular, Abbott, commented “Nearly 3,000 patients around the world have benefited from MitraClip treatment, and we are pleased that it is now commercially available in Australia.”

 

New clinical study to gather additional clinical and health-economic data

 

Abbott also announced the initiation of a new clinical study of the MitraClip device that will enroll up to 150 patients at up to 15 sites in Australia and New Zealand. The primary objective of the single-arm, prospective trial is to gather real-world clinical and health-economic outcome data to evaluate the long-term safety, efficacy and economic value of the MitraClip system. Patients in the study will be evaluated at discharge and after 30 days and six, 12 and 24 months following the procedure.

 

Patients will be selected for inclusion in the study by a multidisciplinary team involving specialists in interventional cardiology, cardiac surgery and echocardiology.

 

David Muller, director of the Cardiac Catheterization Laboratories, St Vincent’s Hospital, Sydney, Australia, and Jurgen Passage, cardiothoracic surgeon, Sir Charles Gairdner Hospital, Perth, Australia, will serve as the principal investigators of the study.

 

About the MitraClip technology and procedure

 

The catheter-based MitraClip device is delivered to the heart through the femoral vein. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. After treatment, patients are usually home within two to three days and have been observed to recover quickly. The safety and efficacy of the MitraClip system was evaluated in EVEREST II, the first randomised clinical trial to compare a catheter-based mitral valve device to mitral valve surgery.

 

The MitraClip system was CE marked in March 2008 and is commercially available in Europe, Turkey, Israel and Australia. The first-in-man clinical trial of the MitraClip system was conducted in the United States, where it is an investigational device currently under review for approval by the FDA.

 

 

 




Add New Comment

Related Items


Most popular


No severe paravalvular leak with Acurate Neo TF
Monday, 29 Sep 2014
Data presented at PCR London Valves (28–30 September, London, UK) indicate that the Acurate Neo transfemoral TAVI system, which recently received the CE mark, is not associated with any incidences of ... No severe paravalvular leak with Acurate Neo TF

ABSORB II study shows Absorb is comparable to Xience drug-eluting stent
Wednesday, 17 Sep 2014
At one year, overall clinical outcomes for Absorb (Abbott) were comparable to Xience (Abbott), and people treated with Absorb experienced a significantly lower rate of angina. ABSORB II study shows Absorb is comparable to Xience drug-eluting stent

First-in-man percutaneous repair of tricuspid valve performed
Wednesday, 08 Oct 2014
Mitralign has reported on the successful use of its technology to perform a percutaneous repair on a patient with tricuspid regurgitation. The company also announced that Joachim Schofer and Rebecca H... First-in-man percutaneous repair of tricuspid valve performed

Features


The promise of chemical renal denervation
Friday, 05 Sep 2014
Tim A Fischell writes that chemical renal denervation using ethanol may have numerous advantages over energy-based “burning” technologies. The promise of chemical renal denervation

Drug-coated balloons for the management of coronary artery disease
Thursday, 04 Sep 2014
Robert Byrne writes that although drug-coated balloon therapy has been a significant innovation with relevance for everyday practice, convincing data in the coronary arena exists thus far only for ... Drug-coated balloons for the management of coronary artery disease

Profiles


Sunil Rao
Thursday, 23 Oct 2014
Sunil Rao speaks to Cardiovascular News about his career highlights, including his research into ... Sunil Rao

Azeem Latib
Wednesday, 24 Sep 2014
Azeem Latib (senior interventional cardiologist, San Raffaele Hospital and EMO-GVM Centro Cuore C... Azeem Latib

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions