FDA Approves Medtronic’s In.Pact 018 Paclitaxel Balloon

Two months after voluntarily recalling a subset of its In.Pact Admiral and In.Pact AV paclitaxel-coated balloon catheters due to manufacturing issues, Medtronic has received FDA approval for a device based on equivalent to the In.Pact Admiral drug-coated balloon (DCB).

The In.Pact 018 DCB is indicated for percutaneous transluminal angioplasty (PTA) of de novo, restenotic or in-stent restenotic lesions with lengths up to 360mm with vessel diameters of 4-7mm. It is designed to cross narrow lesions, provide better deliverability, and is compatible with 0.018 guidewires,” Medtronic said.

The In.Pact 018 will be the only commercially available DCB with an over-the-wire (OTW) catheter length of 200cm, giving physicians the option to treat via femoral or radial access. This is in addition to the OTW catheter length of 130cm.

David Moeller, president of the Peripheral Vascular Health business unit at Medtronic, said the In.Pact 018 was developed in response to physician feedback regarding the need for a 0.018 guidewire-compatible DCB.” .

In.Pact 018 DCB has not been evaluated in a clinical study. However, the company stated that given the design similarities to the In.Pact Admiral DCB, the data from this clinical program of this device can be considered supportive of the new DCB. Medtronic noted that the In.Pact Admiral DCB has been evaluated in 21 clinical studies with more than 3,500 patients. The device has also been used to treat more than 500,000 patients worldwide.

About two months ago, Medtronic voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV drug-coated balloon catheters due to manufacturing issues that damaged the pouch. The company said those issues have since been fixed. Approximately 6,000 IN.PACT Admiral catheters and 3 IN.PACT AV catheters were impacted.

Are Paclitaxel coated devices safe?

In 2019, when the FDA approved Medtronic’s In.Pact AV drug-coated balloon for the treatment of failed arteriovenous access in patients with end-stage renal disease on dialysis, the approval marked a significant turnaround in the history of paclitaxel.

Earlier that year, a meta-analysis showed an increased risk of death in patients treated with paclitaxel balloons and stents. The issue caused the market to drop by around 50% and was the catalyst for a two-day meeting of the Circulatory System Devices Expert Group. The agency concluded at the meeting that there is a signal associated with increased mortality over five years with paclitaxel-coated devices compared to uncoated devices. The FDA was unable to attribute this increased risk to a specific cause, however, and the FDA committee was baffled by the discrepancies in the data.

Above: Joaquin Cigarroa, MD, associate chief of clinical cardiology at the Knight Cardiovascular Institute and voting member of the FDA’s circulatory system expert panel, talks about the signal associated with increased mortality for five years with paclitaxel-coated devices versus uncoated devices. “As we saw yesterday, each of these histogram bars at five years, in the data we have access to, with the recognition that this data is disputed…the signal starts to occur between years three and five, and so I think the models we have to look at are different,” Cigarroa said.

The FDA eased the paclitaxel issue in August 2019, about three months before approving Medtronic’s In.Pact AV paclitaxel-coated balloon. The agency did, however, offer new recommendations for doctors treating patients with paclitaxel balloons and stents:

  • Continue diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
  • When making treatment recommendations and as part of the informed consent process, consider that there may be an increased long-term mortality rate in patients treated with paclitaxel-coated balloons and stents paclitaxel-eluting.
  • Discuss the risks and benefits of all available PAD treatment options with your patients. For many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents offer a more favorable benefit-risk profile based on currently available information.
  • For individual patients deemed to be at particularly high risk for restenosis and repeat femoral-popliteal procedures, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.
  • When discussing treatment options, physicians should explore their patients’ expectations, concerns, and treatment preferences.
  • Ensure patients receive optimal medical treatment for PAD and other cardiovascular risk factors, as well as counseling on healthy lifestyles including weight control, smoking cessation and exercise .
  • Report any adverse events or suspected adverse events related to the use of paclitaxel-coated balloons and paclitaxel-eluting stents. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user organizations must comply with applicable medical device reporting regulations. Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.