When precise deployment matters, so does technology.

To precisely place most balloon-expandable stents, you have to be able to predict how much they will shorten. But precision shouldn’t involve guesswork. That’s why Formula stents are engineered for precision: precise placement, precise treatment and precise conformability

Precise Placement

Formula stents don’t shorten, and their ends align with the balloon markers. These features help you to place the stent and to treat the stricture reliably and precisely.

Precise Conformability

Formula balloon-expandable stents have additional crowns that give their stents a more circular shape and improve their scaffolding.

Precise Treatment

With one of the lowest tip profiles on the market, Formula 418 Biliary can help you cross strictures. The minimal balloon overhang facilitates precise treatment.

The Formula 418 Stent is intended for use in palliation of malignant neoplasms in the biliary tree. The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of biliary duct access sheaths, guiding catheters/ introducers and wire guides should be employed.

CONTRAINDICATIONS

The Formula 418 Stent is contraindicated for use in:

•      Total biliary obstructions and postoperative strictures that cannot be dilated to permit passage of the sheath introducer.

•      Stenting of a perforated duct where leakage from the duct could be exacerbated by placement of a stent.

•      Patients with bleeding disorders.

•      Severe ascites.

WARNINGS

•      Persons allergic to 316L stainless steel may suffer an allergic reaction to this implant.

•      The safety and effectiveness of this device for use in the vascular system have not been established.

•      Stents bridging the papilla should extend no more than 5 mm beyond the papilla and into the duodenum after deployment.

POTENTIAL ADVERSE EVENTS

Adverse events that may be associated with the use of a biliary stent include:

•      Death

•      Stent migration

•      Hemorrhage/hematoma

•      Bile duct dissection, rupture and perforation

•      Sepsis/infection/abscess

•      Total occlusion/obstruction

•      Peritonitis

•      Cholangitis

•      Stent embolization

•      Tumor overgrowth at the stent ends

•      Parenchymal hemorrhage

•      Pancreatitis

•      Hemobilia

•      Stent obstruction secondary to tumor growth through the stent

•      Stent restenosis of the stented bile duct

•      Rupture into a neighboring organ or the retroperitoneum