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Contura multi-lumen balloon catheter

At Hologic, our mission is to make breast cancer intervention and treatment as minimally invasive as possible. Our 5-Day targeted radiation therapy is a breakthrough early stage breast cancer treatment that can offer an alternative to whole breast radiation or a mastectomy. Balloon brachytherapy solutions directly target the lumpectomy cavity, where the cancer is most likely to recur. Patients have a choice - they don't have to undergo five to seven weeks of radiation or potential mastectomy with reconstructive surgery.3 With the Contura multi-lumen balloon catheter, healthy tissues and organs can be spared from the damaging effects of radiation.1

About

The Contura multi-lumen balloon catheter is:

  • Efficient

o    Expedites radiation treatment from five to seven weeks to just five days.

o    Delivers optimal treatment coverage, while minimizing excess radiation to surrounding skin and ribs.

  • Versatile

o    Multiple lumens provide greater flexibility, allowing more women to be candidates for treatment with 5-Day targeted radiation therapy.

o    Balloon catheters range in size from 4.0 – 6.0 cm in diameter, with a broad range of inflation volumes, allowing for the treatment of a variety of cavity shapes and sizes.

o    Built-in seroma management port facilitates the removal of fluid and air from the cavity, ensuring tissue conformance and improved target coverage.

  • Simple

o    Spares healthy tissue and organs from unnecessary radiation, resulting in fewer side effects compared to traditional whole breast radiation.1,2

o    Easy catheter insertion facilitated by an optional introducer sheath and trocar.

 

Features

Seroma management port

  • Ports are located distally and proximally to the balloon, eliminating fluid and air to facilitate tissue conformance and uniform dose.

Lumen configuration

  • Four offset lumens and one central lumen help optimize dosimetric coverage, while minimizing radiation dose to the skin and ribs for improved patient outcomes.
Products
Contura multi-lumen balloon catheter 4.0 - 5.0 cm
 
Contura multi-lumen balloon catheter 4.5 - 6.0 cm
 
Contura multi-lumen balloon catheter 4.5 - 6.0 cm in elliptical shape
Accessories

Cavity maintenance catheter (CMC)

  • Temporarily implanted as a placeholder in the lumpectomy cavity, the CMC preserves the integrity of the pathway to the cavity and facilitates subsequent placement of a balloon catheter for radiation therapy delivery.

Treatment lumen markers

  • Reusable marker kits contain one marker for easy identification of lumen number two, and four identical markers to determine remaining lumens of the Contura multi-lumen balloon catheter.
Important Safety Information

The Contura device is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.  Do not implant the Contura device in patients with extreme or unusual anatomical features, e.g., extreme rib curves or very unequal amounts of breast tissue in the lumpectomy cavity.

The safety and effectiveness of the Contura multi-lumen balloon catheter as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

Please see the Contura IFU for full prescribing information.

References

1. King TA, Bolton JS, Kuske RR, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for Tis1,2 breast cancer. Am J Surg. 2000; 180:299-304.

2. Shah C, Badiyan S, Ben Wilkinson J, Vicini F, Beitsch P, Keisch M, Arthur D, Lyden M. Treatment Efficacy with Accelerated Partial Breast Irradiation (APBI): Final Analysis of the American Society of Breast Surgeons MammoSite® Breast Brachytherapy Registry Trial. Ann Surg Oncol. 2013 Aug 22. [Epub ahead of print] PubMed PMID: 23975302 

3. This is a general information tool for medical professionals and is not a complete representation of the product(s)’ Instruction for Use (IFU) or Package Insert, and it is the medical professionals’ responsibility to read and follow the IFU or Package Insert. For a complete list of contraindications, warnings and precautions, consult the product instructions for use.