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 place the stent and cover the lesion reliably and precisely.

Precise Conformability

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

Precise Treatment

Balloon lengths are customized to reduce the amount of healthy tissue that is dilatated during treatment.

The Formula 418 Renal Balloon-Expandable Stent System is indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic lesion (≤ 18 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 – 7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg systolic or ≥ 10 mmHg mean translesional pressure gradient, or flow-limiting dissection.

CONTRAINDICATIONS

The Formula 418 Renal Balloon-Expandable Stent System is contraindicated for use in:

• Patients for whom antiplatelet and/or anticoagulant therapy is contraindicated.

• Patients who have a lesion that cannot be crossed with a wire or a balloon angioplasty catheter.

• Patients who have stenoses that cannot be dilated to permit passage of the stent.

• Patients with bleeding disorders.

• Stenting of an arterial vessel where leakage from the artery could be exacerbated by placement of a stent.

• Patients with a target lesion with a large amount of adjacent acute or subacute thrombus.

WARNINGS

• The use of this device carries the associated risks of subacute thrombosis, vascular complications, and/or bleeding events. Judicious selection of patients is necessary.

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

PRECAUTIONS

• The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

• Implantation of the stent should be performed only by physicians who have received adequate training. Adequate training consists of specific training in renal stenting techniques and procedures under the supervision of an interventional physician experienced in renal stent implantation.

• Stent placement should only be performed at hospitals where emergency renal artery bypass graft surgery can be readily performed.

• Subsequent restenosis may require redilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of an endothelialized Formula 418 Renal Stent is unknown at present.

Adverse events that may be associated with the use of a renal stent are presented in the following alphabetical list and include, but are not limited to:

• Abscess

• Allergic reaction to stainless steel or contrast agents

• Arrhythmias (ventricular fibrillation, ventricular tachycardia, other)

• Arteriovenous fistula

• Bowel infarct

• Death

• Dialysis

• Dissection

• Drug reaction to antiplatelet agents

• Drug reaction, allergic reaction to contrast media

• Emboli (air, tissue, or thrombotic emboli) resulting in tissue ischemia/infarction

• Emergency surgery to correct vascular complications

• Emergent renal artery bypass surgery

• Extremity ischemia/amputation

• Fever

• Gastrointestinal symptoms from anticoagulation/antiplatelet medication

• Hematoma at vascular access site

• Hemorrhage requiring transfusion

• Hypersensitivity reactions

• Hypotension/hypertension

• Infection and pain at vascular access site

• Intimal tear

• Kidney infarct

• Myocardial infarction

• Myocardial ischemia

• Nephrectomy

• Peripheral neuropathy

• Pseudoaneurysm at vascular access site

• Pseudoaneurysm formation

• Renal artery thrombosis, aneurysm, rupture, perforation, occlusion, spasm, or restenosis

• Renal insufficiency or failure

• Stent migration or embolization

• Stent misplacement

• Stroke/cerebral vascular accident

• Tissue necrosis or ulceration