Recently Approved Medical Devices from Regulatory Authorities:

• AbioCor® Implantable Replacement Heart - H040006
• Karl Storz Rigid TTTS Fetoscopy Instrument Set
• Visian ICL^TM
• LUMA^TM Cervical Imaging System

AbioCor® Implantable Replacement Heart - H040006

Product Name:AbioCor® Implantable Replacement Heart

Manufacturer:Abiomed, Inc.

Approval Date (FDA):September 5, 2005

What is it?The AbioCor is an electrically powered pump (pulsatile electrohydraulic device) used to replace the main pumping chambers (the ventricles) of the human heart. It can deliver up to 8 liters of blood per minute over a broad range of blood pressures. The device consists of a “Thoracic Unit” containing two sealed blood pumps, separated by an energy converter. The Thoracic Unit is connected to the heart’s two upper collecting chambers (the atria) and the two major outgoing vessels supplying blood to the lungs and to the rest of the body. (The heart’s lower pumping chambers, the ventricles, have been removed). The energy converter moves hydraulic fluid from one side of the device to the other, squeezing a sac containing the blood in one side of the pump to force the blood through the connected outgoing vessel. Simultaneously, blood is actively drawn into the pump on the opposite side, filling it for the next cycle, which will discharge blood to the other outgoing vessel.

How does it work?The AbioCor is designed to duplicate the function of the normal heart by circulating blood through the body and the lungs. An implanted controller regulates and monitors the Thoracic Unit. The controller can receive and transmit information by way of radio communication to a system that is external (not connected) to the body, There is also an implanted battery that can operate the implanted system in the absence of the external power source, thereby allowing the patient to be free from all external connections.

A coil implanted under the skin can receive energy (by induction) from an external power source to recharge the implanted battery. An external controlling device allows one to monitor the status of the implantable system and also can alter the system’s operating conditions.

When is it used?The AbioCor is indicated for use in patients who:

• have both major pumping heart chambers (the ventricles) that are failing
• have end-stage heart disease
• are not transplant candidates
• are less than 75 years old
• are not treatable by single left ventricular heart assist devices for destination therapy
• are not able to be withdrawn from heart support measures

What will it accomplish?The AbioCor may provide circulatory support to patients with severe heart failure. Moreover, the device may have the ability to restore normal flow of blood and blood pressures and restore organ function (e.g. kidneys and liver) in patients who are not heart transplant candidates.

When should it not be used?The AbioCor should not be used in patients who are eligible for a heart transplant, in patients where the device will not fit, in patients who cannot be successfully treated for blood clotting disorders or who have only left sided heart failure.

Karl Storz Rigid TTTS Fetoscopy Instrument Set

The Karl Storz Fetoscopy Instrument Sets are surgical tools used in the treatment of twin-to-twin transfusion syndrome (TTTS). TTTS is a rare condition in which there is an imbalance in the amniotic fluid of some identical twins.

Karl Storz Rigid TTTS Fetoscopy Instrument Set

Product Name:

Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 and 12 degree scope, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degree scope, and Karl Storz Semi-Rigid Fetoscopy Instrument SetManufacturer: Karl Storz Endoscopy America, Inc.

What is it?

The Karl Storz Fetoscopy Instrument Sets are surgical tools used in the treatment of twin-to-twin transfusion syndrome (TTTS). TTTS is a rare condition in which there is an imbalance in the amniotic fluid of some identical twins. This imbalance is caused by an uneven flow of blood between the twins through shared blood vessels that are present when the twins share one placenta.

The Karl Storz Fetoscopy Instrument Sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and/or fluid through the entry site. After identifying the shared blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser, which is already cleared for marketing, is used to photocoagulate (destroy with heat) the shared vessels which should help to normalize the flow of blood between the twins.

How does it work?

After a tiny cut in the mother’s abdomen is made, the fetoscope and sheath are inserted through the mother’s abdomen and uterus under ultrasound guidance. Through the fetoscope the surgeon is able to view the placenta and determine which blood vessels are being shared by the twins and which ones are not. The Fetoscopy Instrument Set provides a pathway for a laser that can be used to destroy these shared or shared vessels after they have been identified. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.

When is it used?

After a diagnosis of TTTS is made, the Karl Storz Fetoscopy Instrument Sets can be used for the treatment of TTTS for fetuses whose gestational age is between 16 and 26 weeks (second trimester).

What will it accomplish?

The use of the Karl Storz Fetoscopy Instrument Sets may prolong the pregnancy and improve the odds of survival and lack of complications of one or both twins.

When should it not be used?

The Karl Storz Fetoscopy Instrument Sets should not be used when the following conditions exist:
 

• ruptured membranes
• chorioamnionitis (infection of the membranes or placenta)
• placental abruption (placenta separates from uterus (womb)) or active labor

Visian ICL^TM

The Visian ICL™ (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia) .

Product Name: Visian ICL™ (Implantable Collamer Lens) - Models MICL12.1, MICL12.6, MICL13.2, and MICL 13.7

Applicant: STAAR Surgical Company.

What is it? The Visian ICL™ (Implantable Collamer Lens) is a lens that is permanently implanted in the eye behind the iris and in front of the natural lens. The lens is intended to correct moderate to severe nearsightedness (myopia). This type of lens is called a phakic IOL because the eye still has its natural lens.

How does it work? It works by bending (refracting) light rays to allow them to focus on the retina.

When is it used? The Visian ICL™ is intended for use in healthy eyes, in adults with stable vision. It is designed for:

• The correction of myopia ranging from -3 to -15 diopters (D) with less than or equal to 2.5D of astigmatism at the spectacle plane,
• The reduction of myopia ranging from -15D to -20D anterior with less than or equal to 2.5D astigmatism at the spectacle plane,
• Adults 21-45 years of age with an anterior chamber depth (ACD) of 3.00 mm or greater, and a stable refractive history within 0.5D for 1 year before implantation.

What will it accomplish? The Visian ICL™ may improve a patient’s distance vision without glasses or contact lenses.In a clinical study of 294 patients implanted with the Visian ICL™, 95 percent had 20/40 or better vision (considered standard vision necessary to obtain a driver's license), and 59 percent had 20/20 or better, after three years.

When should it not be used? The Visian ICL™ should not be used in patients who:

• Have an anterior chamber depth less than 3.0 mm as determined by their eye doctor,
• With anterior chamber angle less than Grade II as determined by gonioscopic examination
• Are pregnant or nursing, and
• Do not meet the minimum endothelial cell density as specified in the labeling.

   

LUMA^TM Cervical Imaging System

The LUMA™ Cervical Imaging System is an optical detection system that helps the doctor identify areas on the cervix that may have disease.

LUMA™ Cervical Imaging System

This is a brief overview of information related to FDA's approval to market this product.

Product Name: LUMA™ Cervical Imaging System

PMA Applicant: MediSpectra, Inc.

Approval Date: March 16, 2006


What is it?

The LUMA™ Cervical Imaging System is an optical detection system that helps the doctor identify areas on the cervix that may have disease (i.e., areas that are likely to contain precancerous cells). The doctor uses this device immediately after colposcopy to decide where to take additional tissue samples (biopsies).

How does it work?

The LUMA™ Cervical Imaging System shines a light on the cervix and analyzes how different areas of the cervix respond to this light. The LUMA System assigns a score to tiny areas of the cervix and produces a color map that helps the doctor decide where to biopsy. The colors and patterns on the map help the doctor distinguish between healthy tissue, potentially diseased tissue, and areas that cannot be interpreted (e.g. tissue at the edge of the screen).

When is it used?

The LUMA™ Cervical Imaging System is used immediately after a procedure called colposcopy, a high magnification evaluation of the cervix for women who have recently had an abnormal Pap smear. The doctor first performs colposcopy and identifies areas on the cervix to biopsy. The doctor then evaluates the LUMA™ image to see whether or not there are additional areas of the cervix that should be biopsied. Only after both the colposcopy and LUMA™ procedures are completed does the doctor perform the biopsies indicated from the procedures.

What will it accomplish?

The LUMA™ Cervical Imaging System will help improve the chances that the doctor does not miss an area that may contain precancerous cells.