Boston Sci wins FDA nod for heart failure devices

The FDA has given its blessing to Boston Scientific's ($BSX) INCEPTA, ENERGEN and PUNCTUA CRT-Ds and ICDs to treat heart failure and sudden cardiac death.

In a release, the company touts the devices' ability to deliver better therapy options, battery longevity and a DF4 universal connector system in the industry's smallest and thinnest platform.

The DF4 connector system reduces the volume of Boston Scientific's single-chamber ICDs to 30.5cc and CRT-Ds to 32cc, while maintaining a thickness of less than 10mm. It also simplifies and reduces the time needed for the implant procedure by combining three lead terminals into one integrated connection. Additionally, it uses the new EZ-4 connector tool, which allows physicians to cut back on the number of steps required during implant, the company explained in a statement.

"The DF4 connector system makes the industry's smallest devices even smaller, potentially increasing patient comfort and making the implant procedure quicker and easier for physicians, while the new features will offer even more options for customizing patient care," said Kenneth Stein, CMO of the company's cardiac rhythm management group. "The 4-SITE lead is built on the RELIANCE family of defibrillation leads, which has a demonstrated survival probability of 99 percent at seven years."

In a separate statement, the company said it is providing an extended warranty for these devices in the U.S. and many international markets for up to 10 years, depending on the model. The new warranty is up to 5 years longer than currently available devices.

"Our clinical data show that the majority of patients who have ICDs live more than seven years after implant, and some live for decades," said Robert Hauser of the Minneapolis Heart Institute, Abbott Northwestern Hospital. "The excellent longevity of these devices combined with the length of the warranty has both clinical and financial implications for patients. Greater longevity potentially reduces the number of implant surgeries, which minimizes complication risk and helps improve patient outcomes. The warranty also reduces out-of-pocket expenses for patients as well as healthcare system costs."

- see the Boston Scientific release
- get more on the warranty in this release

Suggested Articles

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients.

OR-focused AI provider Caresyntax has garnered $45.6 million in new funding and picked up a data analytics firm to broaden its footprint.

A study of Foundation Medicine’s FoundationOne liquid biopsy test found it was able to predict the risk that a person’s breast cancer would return.