Ocean Wave


3851 62nd Ave. North Suite A
Pinellas Park, FL 33781

(800) 783-3352                    fax: (727) 527-8696

Contact us via Email: implantabledevices@gmail.com

DUNS #: 081364911

Cage Code: 0UZR5

FEIN: 591732366

NAICS: 339112 (Surgical and medical instrument manufacturing)

SIC Code: 3841 (Surgical and Medical Instruments and Apparatus)

Global Medical Device Nomenclature (GMDN) : the GMDN Preferred Term Name is "Carotid artery shunt" and is defined as: "A sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device."

Carotid Shunt is UNSPSC code 42295512: Surgical implantable shunts or shunt extenders.

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Manufacturer of the patented Doppler Carotid Shunts,

and bringing innovative medical ideas to reality.

Why use a Doppler Carotid Shunt?

Here are some reasons:

  • Peace of Mind –You know the shunt is delivering blood to the brain with the audible signal.
  • Medical Legal – Everyone in the O.R. becomes a witness to having heard the real time verification of the blood flowing.
  • Reimbursement – As Medicare slices through the fees owed to Physicians, some surgeons have reported you can get money back by using a certain CPT code. As a stand alone CPT code, 93882 has worked in the past. Check for updated CPT codes.
  • Anesthesia Monitoring – When deciding to use a shunt to provide the best healthcare for your patient, the patient needs to have a good heart rate with corresponding pressure.  If the rate and pressure drop, the Doppler volume will indicate the change.
  • Scheduling - Occasionally when the EEG Tech is unavailable, and the Surgeon wants to be certain that the Shunt is performing well.

There is a direct relationship of the Doppler signal to the heart rate and blood pressure.  When there is a slower heart rate, the blood flow will undoubtedly slow and the Doppler will make these variables known to you audibly.

Regulatory Document K021608

Regulatory Document K061484


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Clinical Papers about Shunts and Carotid Endarterectomy procedures

Study #1 (Safer shunt insertion...)

Study #2 (Correlation of carotid artery stump pressure...)

Study #3 (Intraoperative measurement of Javid...)

Study #4 (Malfunction of a double-balloon...)

Study #5 (Cerebral Oximetry...)

Study #6 (Poor durability of carotid angioplasty...)

Study #7 (Stenting less safe than surgery...)

Study #8 (Continued higher event rates with stenting vs surgery...)

Study #9 (Clinical and laboratory experience with heprin-impregnated silicone shunts for carotid endarterectomy)

Study #10 (Benefit of Intraop Neuromonitoring May Not Outweigh Costs)

Additional information about the treatment options for Carotid Artery Disease:

New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS)

We'd like to suggest that using a search engine of your choice, one can potentially find more information regarding the ongoing evaluation of new treatment options and how it relates to the use of Carotid Shunts used in Carotid Endarterectomy Surgery.

Contact us via Email: implantabledevices@gmail.com

Dual Balloon Shunt Designs

Dual Balloon Shunt Designs

Dual Balloon Shunt Designs

Dual Balloon Shunt Designs

The dual balloon shunt was originally developed by Toshio lnahara, MD* who endorses the new Doppler feature to monitor continuous blood flow.

*Dr.lnahara's vascular surgery career and some of his many accomplishments.
1. Inventor Carotid Balloon Occlusion Shunt
2. Emeritus Clinical Professor of Surgery OHSU
3. Membership Surgical Societies-11
4. Journal publications 37, Book Chapters 7
5. Founder Pacific Northwest Vascular Society, President 1983-4-5
6. Society for Clinical Vascular Surgery, President 1991
7. Director International Vascular Surgery Fellowship, 1971-93

Seeking Independent Sales Representatives
Please contact us for available territories

Commission based payment; Sales experience appreciated; Medical sales experience desired; A product evaluation will take place in an Operating Room.

(800) 783-3352                               fax: (727) 527-8696

Contact us via Email: implantabledevices@gmail.com

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