The IN.PACT drug-coated balloon is an over-the-wire angioplasty catheter and drug delivery system for treating people with femoro-popliteal peripheral arterial disease (PAD).
NICE cancelled this evaluation because there was a medical device alert which covered the intended use. This has since been withdrawn.
 
Status Discontinued
Decision Selected
Process MTG
ID number 336

Project Team

Project lead N/A

Email enquiries

Stakeholders

External assessment group Kings Health Partners
Manufacturers Medtronic UK
Manufacturers of related technologies not included in scope Boston Scientific
  Terumo
Others Department for Health and Social Care (DHSC)
  Healthcare Improvement Scotland (HIS)
  Johnson & Johnson Medical Ltd
  Medicines and Healthcare Products Regulatory Agency (MHRA)
  NHS England (NHSE)
Professional groups Association of British Healthcare Industries (ABHI)
  Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care (AXrEM)
  British Society of Endovascular Therapy (BSET)
  British Society of Interventional Radiology (BSIR)
  Devices for Dignity
  Medical Technology Group
  Royal College of Physicians (RCP)
  The British In Vitro Diagnostics Association (BIVDA)
  Vascular Society

Timeline

Key events during the development of the guidance:

Date Update
23 May 2024 Discontinued. NICE cancelled this evaluation because there was a medical device alert which covered the intended use. This has since been withdrawn.
19 March 2019 The MHRA has established an Expert Advisory Group to review Paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease. NICE will resume the evaluation after this work has concluded. Please contact medtech@nice.org.uk if you have any queries.
25 October 2018 NICE has become aware of new potentially relevant evidence for this technology and has taken the decision to pause the evaluation until its significance can be assessed. The NICE website will be updated with an updated publication date in due course.
20 July 2018 Committee meeting: 3
23 May 2018 - 21 June 2018 Draft guidance
23 March 2018 Committee meeting: 2
16 February 2018 Committee meeting: 1
20 September 2017 Scope published
21 August 2017 Stakeholder registration opens

For further information on our processes and methods, please see our CHTE processes and methods manual