Here’s a reason for parents of children with a hole in the heart to cheer.
An affordable and effective device that can close the hole and help the children lead a normal life has been developed by doctors of the Hyderabad-based CARE Hospitals.
Called KONAR-MF, the titanium-nickel alloy device is bio-compatible, multifunctional and has benn tested on over 150 patients in Indonesia, the Philippines, and elsewhere.
“We have collaborated with LifeTech, a medical devices company based in Shenzhen province of China, which has obtained the CE mark that gives it access to Europe and Asia-Pacific markets,” said K Nageswara Rao, Chief Paediatric Cardiologist at CARE Hospitals and developer of KONAR-MF.
“We have applied for patents in the US, Europe and India. Approvals from the Indian drug regulator are expected within six months,” Nageswara Rao told BusinessLine.
The company has agreed to set an affordable price, and benefit from government subsidy.
Globally, too, the device will be sold at a competitive price by LifeTech, he said. For the Chinese market, LifeTech will get approvals, while for the USFDA nod a study is being designed for meeting the requirements, he said.
According to available data, the incidence of a congenital heart disease is 10 out of 1,000.
About 25 per cent of these patients end up with a hole in the heart. Called Ventricular septal defect (VSD) , the hole can lead to heart failure, pulmonary hypertension, and other complications.
The reasons for the heart condition are consanguineous marriage, pesticide exposure, Rubella and some key vitamin deficiencies, said Nageswara Rao.
The treatment solutions available are open heart surgery and catheterisation. However, reports on the failure of some of the devices have necessitated improvements in the line.
In this scenario, KONAR-MF offers the best hope, especially for those with VSD. The device has been tested on children from one year and above.
Among its several advantages are easy implant procedure, and designing the patch precisely to the size of the hole, says Rao.
The device also holds promise for a variety of other conditions such as fistula and paravalvular leaks.
culled from the hindu business line